Volume 25 Number 1 March 2016 Medical Writing
Authors and Authorship Also in this issue... • Returning to full-time employment after freelancing • Freelance business survey Authors and authorship 1 • First data on the reproducibility of Phillip Leventhal research published in Science • The HAP score for granting authorship of Letter from the editor: 3 large multi-center trials A step – no a leap – forward • Restoring study 329: reanalysis of a Phillip Leventhal paroxetine trial with the same data with opposite conclusions Medical Writing is the official President’s Message 4 journal of the European Medical In the Bookstores 36 Writers Association (EMWA). It is a Feature Articles • The Elements of English Editing: quarterly journal that publishes A Guideline to Clear Writing articles on topics relevant to Ghostwriting prevalence among 6 • Visual Complexity: Mapping Patterns of professional medical writers. AMWA and EMWA members Information Members of EMWA receive Medical (2005 to 2014) 58 Writing as part of their membership. Cindy Hamilton and Adam Jacobs The Webscout Authors and authorship For more information, contact The sun never sets on transparency 13 [email protected] Regulatory Matters 59 Kim Pepitone and Brian Sharkey • Authorship issues in regulatory Submissions: GPP3 – what is it, why is it necessary 21 documents For instructions to authors, go to the and what is new? English Grammar & Syntax 61 journal section of EMWA's website Keith Veitch (www.emwa.org). All manuscripts • Good Writing Practice: should be submitted to Attribution, advocacy, disposable 25 • Writing abstracts for congresses [email protected]. authors, corporate ghosts and cultural Medical Communication 62 assimilation: new themes in the ethical • Poacher turned gamekeeper Editor-in-Chief critique of commercial medical literature Phillip Leventhal Alastair Matheson Lingua franca and beyond 64 • Choosing a collaborator Co-Editor Perspective from a leading scientific 30 65 Stephen Gilliver author: An interview with Professor Gained in Translation Ruth Roberts on authors and authoring • Authoring medical translations – to MD or not MD? Associate Editors Andrew Walker • Which background makes a better Joselita T Salita 33 medical translator? Raquel Billiones Authorship of clinical trial documents Raquel Billiones Anuradha Alahari Medical Writing Teaching 70 Barbara Grossman Project management in medical 36 • A novice’s experiment with a Katharine Webb publication writing: A less explored wiki on a writing course avenue in pharmaceutical companies and Profile 72 Section Editors clinical research organisations • Phil Leventhal, Kathryn White Prashant Auti and colleagues Alison Mcintosh Editor-in-Chief of Medical Writing Karin Eichele Never say never! – Returning to 44 EMWA News 72 Greg Morley full-time employment after freelancing • EMWA’s 2016 Webinar Programme Alistair Reeves Alison Mcintosh Wendy Kingdom Out on Our Own 73 Lisa Chamberlain-James Fifth EMWA freelance business survey 47 • Editorial Barry Drees Johnathan Edwards and colleagues • The start of a year in Germany as a Maria Koltowska-Haggstrom freelance medical writer Laura Collada-Ali Regular Features • Medical translation – a dead-end job or Beatrix Dörr a gateway to opportunity? Part 1 Hervé Maisonneuve Journal Watch 54 • Are you having the impact you want • The COMPARE project with your clients? Copy editor/reviewer • Journals should publish referee reports Amy Whereat and respond to well-founded concerns about papers after publication Editor Emeritus • Are meta-analysis simple works, office- Elise Langdon-Neuner based, cheap, time-efficient with chances to be highly cited?
March 2016 Medical Writing | Volume 25 Number 1 Volume 25 Number 1 March 2016
Medical Writing
Authors and Authorship
Phil Leventhal, Editor-in-Chief
Authorship of medical journal articles has been and continues to be sponsored biomedical research a complicated subject. The unethical practices of guest, honorary, and publications.” GPP2, in 2009,3 and ghost authorship and incomplete or biased disclosure of clinical trial GPP3, just published in 2015,4 data have led to guidelines meant to eliminate these practices. The were designed to further clarify International Committee of Medical Journal Editors (ICMJE) some of the grey areas. They also introduced the contributor ship Recommendations,1 first published in 1979, and Good Publication model of authorship, where authors need to specifically state how Practice (GPP) guidelines, first published in 2003,2 have led the way. they satisfied the criteria for authorship. A main goal of GPP3 is to eliminate the practices of guest authorship and ghostwriting. It also The current ICMJE guidelines1 stipulate that authors of medical discusses in detail the valid role of medical writers and provides journal articles should make substantial contributions to: recommendations on how authors of publications should work with • The conception or design of the work; or the acquisition, a medical writer. analysis, or interpretation of data for the work; AND By the way, EMWA’s position on ghostwriting is articulated in its • Drafting the work or revising it critically for important Ghostwriting Position Statement.5 It insists that “medical writers have intellectual content; AND a legitimate role in assisting named authors” and should not be • Final approval of the version to be published; AND referred to as ghostwriters because our contributions, and funding • Agreement to be accountable for all aspects of the work in for our work, should not be secret and should instead be openly ensuring that questions related to the accuracy or integrity of acknowledged. The American Medical Writers Association (AMWA) any part of the work are appropriately investigated and resolved. takes a similar stance in their position statement.6 Most journals now require that authors meet at least the first three These authorship criteria mean that adding an author after the fact of the ICMJE authorship criteria, and most companies require their – a guest or honorary author – is not acceptable. The third and fourth employees to follow GPP guidelines, but that does not necessarily criteria are meant to prevent authors from denying responsibility for mean that the practice of ghost authorship has disappeared. Based on any of the article’s content. In their current state, the ICMJE the results of surveys of EMWA and AMWA members conducted authorship criteria also generally preclude medical writers from being between 2005 and 2014, Cindy Hamilton and Adam Jacobs report authors because they usually cannot (or are unwilling to) satisfy in this issue that although the practice has decreased, approximately criteria 3 and 4. Finally, the ICMJE guidelines state, “Contributors one-third of respondents were aware of ghostwriting as a continuing who meet fewer than all 4 of the above criteria for authorship should problem. Clearly, unethical authorship practices continue and more not be listed as authors, but they should be acknowledged.” This work needs to be done to wipe them out. means that the contributions of medical writers and editors should Alastair Matheson argues that even if these guidelines, be transparently and clearly stated in the recommendations, and position statements were acknowledgments. followed perfectly, they do not go far enough – that As explained by Keith Veitch in this issue of CONTACT we should be discussing not just authorship but Medical Writing, GPP, first published in 2003, was ✒ Phillip Leventhal attribution, which he defines as “what the article designed to reinforce the ICMJE guidelines and ● [email protected] communicates to readers about its stakeholders, “establish clear guidelines and standards for industry- origins, and development.” In particular, he says that
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 1 Editorial
in industry-sponsored publications, there is a systematic over - emphasis on academic recruits and downplaying of the sponsoring Also in this issue companies, with the specific intent of using “key opinion leaders” that Last but not least, long-time EMWA member Alison McIntosh had nothing to do with the study as product advocates. He says that talks about her return from freelancing to full-time employment. this unethical practice should be eliminated but that it is consistent This should be interesting to the many full-time medical writers with existing guidelines and recommendations. In his article, he who fantasize about the independence of freelancing, as well as suggests specific steps to ensure that companies are assigned the the many freelancers who are considering sacrificing self- “dominant authorial role” in industry-financed publications. determination for stability. Thanks to increasing awareness of the potential for unethical advocacy practices and bias, the US enacted the Sunshine Act in 2010. The Sunshine Act, and its European equivalents, require disclosure of transactions or “transfers of value” between industry and healthcare practitioners. Kim Pepitone writes about the effects of this legislation A main goal of on medical writers and authors. She GPP3 is to eliminate explains that, unfortunately, the practices of guest whether industry support for authorship and medical writing and editorial services should be reported ghostwriting. It also remains unclear. She says that discusses in detail the valid requiring authors to report it role of medical writers and may scare away potential study provides recommendations investigators or result in refusal on how authors of of authorship by someone who publications should should receive it, surely not the intent of the legislation. References work with a medical Although most conver sat ion 1. International Committee of Medical Journal Editors. The New writer. about authorship focuses on publicat- ICMJE Recommendations (August 2013). 2015 ions, Raquel Billiones explains that [cited 2016 Jan 21] Available at: http://www.icmje.org/ authorship of clinical trial documents also news-and-editorials/new_rec_aug2013.html. deserves scrutiny. It turns out that authorship of these documents is 2. Wager E, Field EA, Grossman L. Good publication practice for far less well defined for clinical trial documents than for publications. pharmaceutical companies. Curr Med Res Opin Little guidance is available in current ICH (International Committee 2003;19(3):149–54. for Harmonization) guidelines. This will hopefully change following 3. Graf C, Battisti WP, Dan Bridges D, et al. Good publication publication of the recommendations of the CORE (Clarity and practice for communicating company sponsored medical Openness in Reporting: E3 based) Reference project,7 which is led research: the GPP2 guidelines. BMJ 2009;339:b4330. by EMWA President Sam Hamilton and will be co-published this 4. Battisti WP, Wager E, Baltzer L, et al. Good Publication Practice spring here in Medical Writing and in the journal Implementation for communicating company-sponsored medical research: Science. GPP3. Ann Intern Med 2015;163(6):461-4. Finally, two articles in this issue of Medical Writing provide 5. Jacobs A, Wager E. European Medical Writers Association practical advice on how medical writers can best work with authors (EMWA) guidelines on the role of medical writers in developing on publications. In the first of these, Andrew Walker interviews peer-reviewed publications. Curr Med Res Opin 2005;21: Professor Ruth Roberts, who has published over 130 peer-reviewed 317-21. research articles and reviews. In the interview, Professor Roberts 6. Hamilton CW, Royer MG. AMWA position statement on the describes some of the main challenges when working with co-authors contributions of medical writers to scientific publications. including determining who will and will not be listed as a byline AMWA Journal 2003;18:13-16. author. In the second of these two articles, Prashant Auti and 7. Hamilton S., Seiler W., Gertel A. The EMWA Budapest Working colleagues discuss project management in publications writing. Their Group: a 2-year collaboration to make recommendations for article describes a specific project management approach that can aligning the ICH E3 guideline with current practice and simplify and speed the delivery of publication writing projects. developing clinical study protocol guidance. Medical Writing 2014;23(4):281-8.
2 | March 2016 Medical Writing | Volume 25 Number 1 Editor’s Message
Letter from the Editor
A step – no a leap – forward authors can now reuse or republish all or part of their text without In 2012, the journal’s precursor, The Write Stuff, became Medical asking for permission. We only ask that if text is used verbatim, Writing under the guidance of then Editor-in-Chief Elise Langdon- authors cite the original publication in Medical Writing and state that Neuner. The Write Stuff had been managed almost single-handedly it was first published there. by Elise, and the shift to a publishing house was designed to simplify operation while bringing the journal to a wider international audience New look that included subscribers outside of EMWA. As part of this, the You might have noticed the new look of this issue. I hope that you like journal adopted a more academic look, style, and name. it. Every issue will now have a different cover. We also selected fonts Later the same year, Elise stepped down, handing the editorship and formatting, not to mention colour images, to give the journal a over to me. The last three and a half years has presented a variety of more magazine-like look. Our aim is to better reflect that Medical challenges but also many rewards. I feel strongly that we have added Writing is a combination of a journal, magazine, and professional to the depth, quality, and usefulness of the articles. newsletter and not an academic journal. Over the years, I have had informal discussions with many EMWA members about what they would like from the journal. Some of the Open access main suggestions were to move away from the academic look and feel The idea of making Medical Writing open access had been tossed of the journal, make the journal open access, and eliminate copyright. around for several years, but each time the issue was raised, it was We worked hard to address some of these issues, but most were voted down out of concerns that it would cause EMWA to lose unattainable due to the limitations of our contract with and the members. Following a discussion on LinkedIn, we decided to let operations of our publisher. EMWA members vote on it. Based on the responses to that survey On January 1, we shifted Medical Writing to a printing house, and considering practical issues in running the journal website, we moved control of the journal in-house, and added an Editorial Assist - have decided to make all feature articles available open access. Regular ant to help handle management of the journal. This created the sections, however, will remain limited to EMWA members. In opportunity to seriously consider the suggestions I have received over addition, the journal will now appear on Google Scholar and therefore the years. also on Google, which should increase the international profile of EMWA, our members and contributors to the journal. Copyright As part of our contract New journal website with our former pub- Access to Medical Writing, and The Write Stuff archive, is now available lisher, copyright for all at journal.emwa.org and will no longer be available via the publisher’s content had to be website. New versions of the instructions for authors and the template assigned to EMWA. for writing feature articles can also be found there. The website Elise and the EMWA features a nice search option as well as author bios, with the eventual Executive Committee goal of linking them to Google Scholar profiles. worked hard to ensure that copyright remain - How to contact Medical Writing ed at least with EMWA All requests for information about Medical Writing and article and not the publisher. submissions should now be sent to our Editorial Assistant at However, this still [email protected]. Our Editorial Assistant is housed at EMWA’s Head created an awkward and Office, which will improve communication between the journal and complicated situation, not other parts of EMWA’s operations. to mention a lot of concern, especially by our freelance Tell us what you think members. We hope that you like these changes to Medical Writing. If you have Copyright assign- any comments or suggestions, or if you are interested in getting ment is no longer involved or contributing an article, please write to us at necessary as of [email protected]. January 1. Copy- right will now remain with the authors. This Phil Leventhal means that Editor-in-Chief
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 3 President’s Message
President’s Message
Dear EMWA Members, It is my very great pleasure to ‘speak’ to you from the The SIGs allow follow-up to CORE Reference. RPD SIG will focus pages of the very first issue of Medical Writing of 2016, on public disclosure of clinical regulatory with our new printer, Hastings. I am particularly EMWA and its documents, with the expectation that their content excited that our feature articles are now open-access – members to and structure will be impacted; that their range will a progressive and forward-thinking move for EMWA increase; and that public disclosure will create the and its journal. Not only will authors benefit from an contribute to need for new documents, which the medical writer expanded audience, but EMWA will also increase its important will support. The SIGs allow EMWA and its global reach and ability to influence the medical members to contribute to important conversations writing industry. conversations around topics that we know will impact our Our Munich spring conference is just around the around topics that industry in the coming years. corner and your Executive Committee (EC) and an We will also trial an internship forum, where army of volunteers have been working hard these past we know will impact potential internees new to medical writing and 10 months to put together another stimulating our industry in the companies seeking interns can network. programme. With something for everyone – from entry-level If we look back on the past 22 months, we see that coming years. right through to experienced members – our spring conference content has flourished from a I invite you to join us in lively Munich from 10th to sound offering of workshops with Symposium Day back in 14th May 2016 for another memorable conference. May 2014, into the complex multi-layered programme that we offer you in May 2016. We should all be proud of EMWA’s maturation. Best wishes, As usual, foundation and advanced workshops, the Freelance Sam Hamilton Business Forum and the buzz of medical writers networking will underpin the conference. The 4th Symposium Day on ‘Scientific and Medical Communication Today’ will bring us together with cross- industry speakers, panellists and regulators for lively debate on our ever-changing professional landscape. Experienced members will enjoy the 2nd Expert Seminar Series, covering topics as diverse as clinical trial disclosure; referencing software; running medical writing groups in India, China and Japan; artificial intelligence and adaptive study design. Special Interest Groups (SIGs) will provide EMWA’s very own ‘talking shops’ on hot topics that are expected to develop and endure. The Pharmacovigilance Special Interest Group (PV SIG) will delve into issues that impact the PV documents that we write, and with the direct involvement of regulators, you can ask the questions that matter to you. As EMWA and AMWA (American Medical Writers Association) publish the open-access resource CORE (Clarity and Openness in Reporting: E3-based) Reference in May 2016, we will launch the Regulatory Public Disclosure SIG (RPD SIG), a natural
4 | March 2016 Medical Writing | Volume 25 Number 1 www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 5 Peer-reviewed article Ghostwriting prevalence among AMWA and EMWA members (2005 to 2014)
Cindy W. Hamilton1 and Adam Jacobs2 1 Virginia Commonwealth University School of Pharmacy, Richmond, VA, USA and Hamilton House Medical and Scientific Communications, Virginia Beach, VA, USA 2 Premier Research, Wokingham, UK
Correspondence to: Cindy W. Hamilton, 844 Quail Point Cove, Virginia Beach VA 23454 USA; Phone: (757) 481-2799; Email: [email protected]
This article is being co-published in the Spring 2016 issue of the AMWA Journal (Volume 31, Issue 1).
Abstract Introduction: Ghostwriting, defined as undisclosed substantial contributions by medical writers, is considered to be unethical by the American Medical Writers Association (AMWA), EMWA, and other professional associations.
Methods: To determine the prevalence of ghostwriting among medical writers coincident with educational campaigns, we initiated a Web-based, self-administered, confidential survey of AMWA and EMWA with more authorship guidelines were less EMWA members who made substantial members in 2005 and repeated it in 2008, likely to have undisclosed contributions; contributions to manuscripts), our findings 2011, and 2014. We focused on manuscripts regression coefficients ranged from -6.6 suggest the need for further collaborative to which survey participants had made (95% CI, -8.5 to -4.8) in 2005 to -10.6 in efforts to promote transparency and to substantial contributions and now report 2014 (95% CI, -13.1 to -8.0; all P values conduct research about how to achieve best final findings from all surveys. <0.001). practices in medical publication. Results: The number of participants with valid data was 843 in 2005, 773 in 2008, 620 Conclusions: The 44% decrease in the rate Introduction in 2011, and 410 in 2014. The mean of manuscripts with undisclosed contrib - “A lack of transparency results weighted percentage of manuscripts with utions between 2005 and 2014 is encourag - in distrust and a deep sense undisclosed contributions was 61.8% (95% ing, but the 34% rate of ghostwriting among of insecurity.” confidence interval [CI], 59.0 to 64.6) in medical writers remains unacceptable. – Dalai Lama 2005, 41.7% (95% CI, 38.6 to 44.7) in 2008, While these findings should not be gener- 33.0% (95% CI, 29.7 to 36.3) in 2011, and alised to the overall prevalence of ghost- Ghostwriting, defined as undisclosed sub- 34.4% (95% CI, 30.2% to 38.5%) in 2014. writing in the literature (because survey stantial contributions by medical writers to In univariate analyses, participants familiar participation was restricted to AMWA and manuscripts published in medical journals,
6 | March 2016 Medical Writing | Volume 25 Number 1 Ghostwriting prevalence amongst AMWA and EMWA members (2005 to 2014)– Hamilton / Jacobs
has long been recognised as unethical.1 medical writers to scientific commun ic at - groups of medical writers. The 2005 survey Without transparency, readers are denied ions.15 To further improve awareness among instrument comprised 13 multiple-choice the opportunity to judge the potential members, AMWA subsequently developed questions and one open-ended question influence by groups with special interests new ethics workshops and, in 2010, began about the practices and experiences of and other conflicts. Allegations of bias and requiring an ethics workshop for com - medical writers who make substantial other transgressions have a domino-like pletion of each AMWA certificate. EMWA contributions to manuscripts intended for effect and tarnish not only the reputations and ISMPP also undertook educational submission to medical journals (see Supp - of medical communicators but also the campaigns. lementary Material). Subsequent surveys entire profession of medical communication Ghostwriting is presumed to be were identical to the 2005 survey, except for as well as their sponsors.2-4 widespread, but a recent systematic review the addition of a question about the type of During the last 10 to 15 years, prof ess - has shown that estimates have often been manuscript to which participants had made ional and trade organisations representing based on anecdotal evidence, statements substantial contributions (question 11). medical writers, journal editors, and the taken out of context, and confusion about Some questions allowed for internal pharmaceutical industry have attempted to authorship criteria.16 Furthermore, the validation of responses. For example, clarify and expand authorship guidelines, prevalence was unknown among medical participants were considered to have invalid including how to distinguish the legitimate writers in the early 2000s. To determine the data if they indicated that 90% or 100% of role of professional medical writers from prevalence of ghostwritten manuscripts manuscripts did not disclose their that of ghostwriters. For example, the among AMWA and EMWA members substantial contributions (question 3), that American Medical Writers Association before, during, and after implementation of they always or usually requested acknow - (AMWA) adopted a position statement on educational initiatives, we initiated a series ledgment when they made substantial the contributions of medical writers to of surveys in 2005. Our secondary objective contributions (question 7), and that this scientific publications in 2002,5 and the was to determine the prevalence of medical request was always or usually granted European Medical Writers Association writers’ requests for acknowledgment and (question 8). In other words, contradictory (EMWA) published more detailed guide - variables associated with acknowledgment. responses to question 3 compared with lines in 2005.6 In 2005, the International The preliminary results from each survey questions 7 and 8 were considered to be Society of Medical Publication Professionals have been previously presented, usually as invalid. Participants with invalid data were (ISMPP) was founded to enhance medical conference posters or presentations.17-20 excluded from the analyses. If participants publication integrity and transparency and The purpose of this article is to report answered any parts of question 5 about to improve standards and best practices. complete and final findings from all four familiarity with relevant guidelines but did Recently, ISMPP supported the develop - surveys. not answer whether or not they were ment and publication of the third version of familiar with any specific guideline, then we the Good Publication Practice (GPP3) for Methods assumed that they were not familiar with cx The International Committee of Medical The methods have been reported prev - that guideline. Otherwise, missing data were Journal Editors (ICMJE) increased the iously18 and are reproduced with modific - ignored with no attempt at imputation. number of authorship criteria and made ations as needed to accommodate more All statistical analyses were done using them more specific.8-12 The Pharmaceutical recent surveys. A series of surveys was Stata version 8.2 or later (StataCorp, College Research and Manufacturers of America conducted over 3-week periods in October Station, Texas). The primary analysis was (PhRMA)13 also updated their guidelines. or November of 2005, 2008, 2011, and calculation of mean percentage of manu - These professional organisations now agree 2014, using an Internet survey tool (Survey scripts containing undisclosed contribut - that medical writing assistance is acceptable Monkey; www.surveymonkey.com). Survey ions in the last year (question 3) weighted provided that both substantial contributions methods were identical, apart from the in proportion to the number of manuscripts to manuscripts and any potential conflicts of addition of a single question from 2008 to which participants had made substantial interest are disclosed. onward as described in the next paragraph. contributions and that were intended for Coincident with efforts to clarify guide- All AMWA and EMWA members were submission to medical journals during an lines, medical writing organisations launched invited by email to participate in the survey; average year (question 2). The response campaigns to educate stakeholders about one or two email reminders were sent. No category >20 manuscripts/year was transparency and other best practices. For incentives were offered. To encourage assumed to be 25 manuscripts/year. The example, AMWA appointed a task force in participation, we promised that responses 95% confidence interval (95% CI) was 2001,14 which recommended a stepwise would be anonymous and the survey would calculated assuming that responses were process beginning with publications and take only 5 min to complete. normally distributed. An unweighted mean presentations to educate the medical We developed the survey instrument and 95% CI were also calculated similarly. community about the contributions of using repeated rounds of pilot testing among The assumption behind the calculation of
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 7 Hamilton / Jacobs – Ghostwriting prevalence amongst AMWA and EMWA members (2005 to 2014)
95% CIs was checked by calculating proportion of review papers was included in sizes of the organisations, more participants bootstrap confidence intervals as a the multivariate analyses as an extra were members of AMWA than EMWA. In sensitivity analysis. Because there was good independent variable in the 2008, 2011, and 2014, 52 participants reported that they agreement between the normal distribution 2014 data. No formal statistical comparisons were not members of either organisation CIs and the bootstrap CIs, the bootstrap CIs were made between surveys because this and were excluded from further analysis. are not presented here. was not a pre-specified objective when the The mean, weighted percentages of Secondary analyses were done to test the 2005 survey was planned. manuscripts with undisclosed contributions null hypothesis that familiarity with relevant were 61.8% (95% CI, 59.0% to 64.6%) in guidelines (question 5) was not associated Results 744 participants in 2005 and 34.4% (95% with frequency of undisclosed contrib - The survey participation rate ranged from CI, 30.2% to 38.5%) in 354 participants in utions. Linear regression analysis was used 28% (1537 participants/5463 email 2014, for an overall decrease of 44.3% to test whether the percentage of invitations) in 2005 to 8% (464/5664) in (Figure 1). The mean, unweighted per - undisclosed contributions was associated 2014, which suggests that both the per - centages of manuscripts with undisclosed with the number of guidelines with which centage and number of survey participants contributions were 58.8% (95% CI, 55.8% the participant was familiar (maximum 5, decreased over time (Table 1). Participants to 61.8%) in 750 participants in 2005 and minimum 0). represented a wide variety of types of 26.4% (22.4% to 30.4%) in 355 participants Further exploratory analyses investigated employment, years of experience, and in 2014. the potential association between undis - numbers of manuscripts – with no obvious Survey participants’ experience of and closed contributions and other variables changes over time (Table 2). In each survey practice in requesting acknowledgment (i.e., number of manuscripts to which year, the largest single employment category were generally consistent with trends in the participants had made substantial contrib- was freelance. Consistent with the relative percentages of manuscripts with un - utions during an average year, familiarity with each of the five guidelines specifically, type or place of employment, number of Participants Number (%) years of experience in medical comm - 2005 2008 2011 2014 unication, and membership in professional Invitations sent by email N = 5,463 N = 6,563 N = 6,084 N = 5,664 organisations). These associations were All participants 1,537 (28) 929 (14) 725 (12) 464 (8) investigated in an exploratory sense in both Contributing participants 943 (17) 839 (13) 658 (11) 437 (8) univariate and stepwise multivariate Participants with valid data 843 (15) 773 (12) 620 (10) 410 (7) analyses, with thresholds of P > 0.1 for Member of AMWA or EMWAa 843 (15) 773 (12) 620 (10) 358 (6) removing variables and P < 0.05 for re-entry. a Participants could be a member of both AMWA and EMWA. Results were analysed in an identical manner for all surveys, except that the Table 1. AMWA and EMWA members who participated in the surveys
8 | March 2016 Medical Writing | Volume 25 Number 1 Ghostwriting prevalence amongst AMWA and EMWA members (2005 to 2014)– Hamilton / Jacobs
Our survey findings provide unique insights into the prevalence of ghostwriting among medical writers during the last decade. disclosed contributions (Table 3). For survey year, participants who were familiar only one to two papers per year; P < 0.05 in example, the percentage of participants who with more guidelines were less likely to have 2005, 2011, and 2014) and to review-type reported a decreased prevalence of ghost - undisclosed contributions. Specifically, the articles (relative to original-research articles; writing was 39% (270/688) in 2005 and regression coefficients for the change in P < 0.05 in 2008 and 2011). Similarly, 64% (217/339) in 2014. The percentage of percentage of undisclosed contributions for ghostwriting was associated with being a participants who requested disclosure of familiarity with each additional guideline freelance writer (relative to being employed their contributions was 50% (370/747) in was -6.6% (95% CI, -8.5% to -4.8%) in 2005, by a hospital, university, or medical school; 2005 and 79% (282/357) in 2014. The -7.7 (95% CI, -9.6% to -5.8%) in 2008, - P ≤ 0.01 in 2005 and 2008). Disclosure was percentage whose requests for disclosure 7.7% (95% CI, -9.5% to -5.8%) in 2011, and associated with familiarity with guidelines were granted was 83% (304/365) in 2005 -10.6% in 2014 (95% CI, -13.1% to -8.0%; from AMWA, EMWA, GPP, ICMJE, and and remained high in 2014 (95% all P values <.001; data not shown in tables). PhRMA. Of these, ICMJE was significant in [267/281]). The percentage of participants This means that writers made, on average, all four survey years (P < 0.001), with who encouraged authors and other cont rib- 10.6% fewer undisclosed contributions for regression coefficients ranging from -14.0% utors to follow ICMJE guidelines was 55% each guideline with which they were familiar (95% CI, -20.4% to -7.6%) in 2005 to - (332/609) in 2005 and 81% (276/341) in in 2014, and the interpretation of the 20.5% (95% CI, -31.5% to -9.4%) in 2014. 2014. regression coefficients is similar in other Reported familiarity with guidelines years. Discussion appeared to increase over time (Figure 2). In the stepwise multivariate analyses, Our survey findings provide unique insights For example, the percentage of participants ghostwriting or disclosures were associated into the prevalence of ghostwriting among who were familiar with ICMJE guidelines with eight variables in at least two survey medical writers during the last decade. The was 54% (399/735) in 2005 and 85% years (Table 4). Ghostwriting was assoc - mean, weighted percentage of manuscripts (304/356) in 2014. iated with making substantial contributions with undisclosed contributions was 62% in In univariate analyses of data from each to more than10 papers per year (relative to 2005, fell sequentially in the next two
Characteristic Number of Responses (%) 2005 2008 2011 2014 Employment N = 746 N = 662 N = 523 N = 358 Self-employed or freelance 289 (39) 260 (39) 240 (46) 158 (44) Pharmaceutical, biotech, or medical device company 208 (28) 154 (23) 106 (20) 69 (19) Medical communication, medical education, or PR112 (15) 131 (20) 67 (13) 52 (14) Hospital, university, or medical school 77 (10) 57 (9) 62 (12) 49 (14) Contract research organization 32 (4) 32 (5) 21 (4) 14 (4) Other 28 (4) 28 (4) 27 (5) 16 (4) Years of experience N = 737 N = 657 N = 514 N = 350 0–2 85 (12) 87 (13) 49 (10) 41 (12) 3–5 158 (21) 157 (24) 88 (17) 66 (19) 6–10 208 (28) 160 (24) 117 (23) 77 (22) 11–15 106 (14) 115 (18) 99 (19) 56 (16) 16–20 71 (10) 55 (8) 61 (12) 42 (12) >20 109 (15) 83 (13) 100 (19) 68 (19) Number of manuscripts in an average year N = 776 N = 691 N = 559 N = 356 1–2 169 (22) 131 (19) 95 (17) 41 (12) 3–5 275 (35) 229 (33) 189 (34) 133 (37) 6–10 184 (24) 188 (27) 154 (28) 93 (26) >10 148 (19) 143 (21) 121 (22) 89 (25) Membership N = 736 N = 647 N = 520 N = 358 AMWA 631 (86) 500 (77) 424 (82) 252 (70) EMWA 127 (17) 166 (26) 110 (21) 121 (34) PR, public relations
Table 2. Characteristics of participants with valid data across survey years
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■ 2005 ■ 2008 ■ 2011 ■ 2014 80
60 and Practices Initiative (MPIP) evaluated familiarity with and reliance on authorship guidelines among four stakeholder 40 groups.23 Nearly 500 people, with good representation in each group, participated in the online survey. Most medical writers 20 (88%), publication professionals (97%), and journal editors (89%) were aware of Ghostwritten manscripts - % ICMJE authorship criteria; however, only 0 49% of clinical investigators were familiar Weighted Unweighted with these guidelines. Also, medical writers (51%), publication professionals (70%), Figure 1. Prevalence of ghostwriting across survey years. Error bars represent 95% CIs. and journal editors (59%) were more likely to rely on these guidelines than clinical surveys to a low of 33% in 2011, and regression coefficients suggesting that investigators (28%).23 Like MPIP, the persisted at 34% in 2014. While the rate participants familiar with ICMJE guidelines Global Publication Survey studied current remained unacceptably high in 2014 and had 14% to 21% fewer undisclosed practices and implementation of publication failed to sustain the improvement seen in contributions compared with those who guidelines among nearly 500 stakeholders,24 the first three surveys, the overall decrease were not familiar with these guidelines. especially employees at medical comm un - was 44% between the first and last surveys. Decreases in the rates of undisclosed ication agencies (51%) and at pharm - This drop is noteworthy, particularly when contributions between 2005 and 2008 and aceutical or device companies (30%). Again, combined with the results of regression again between 2008 and 2011 coincided the majority of both agency and industry analyses. There were strong correlations with international efforts to clarify pub - participants routinely referred to ICMJE for between disclosures and familiarity with lication guidelines5, 6, 8-11, 15, 21 and increase guidance on ethical practice (93%).24 In guidelines in both univariate and stepwise awareness of them.14,15, 22 2014, 85% of our survey participants were multivariate analyses, some of which The high level of guideline awareness in familiar with ICMJE guidelines. Also in our persisted throughout the four surveys. For our 2014 survey is consistent with that in 2014 survey, 79% of participants requested example, disclosure was associated with other recently reported surveys.23,24 For disclosure of their contributions and 95% familiarity with ICMJE guidelines, with example, the Medical Publishing Insights reported that their requests for disclosure
Type of experience or practice Number (%) 2005 2008 2011 2014 Perceived change in prevalence of ghostwriting in last 5 years N = 688 N = 651 N = 526 N = 339 Decreased to none 20 (3) 72 (11) 95 (18) 51 (15) Decreased but still occurs 250 (36) 340 (52) 275 (52) 166 (49) No change 360 (52) 198 (30) 137 (26) 107 (32) Increased 58 (8) 41 (6) 19 (4) 15 (4) Request acknowledgment N = 747 N = 665 N = 533 N = 357 Always 187 (25) 288 (43) 309 (58) 205 (57) Usually 183 (24) 168 (25) 118 (22) 77 (22) Rarely or never, but I am not opposed 354 (47) 194 (29) 99 (19) 73 (20) Rarely or never because I am opposed 23 (3) 15 (2) 7 (1) 2 (1) Requests for acknowledgment granted N = 365 N = 466 N = 424 N = 281 Always 127 (35) 224 (48) 257 (61) 173 (62) Usually 177 (48) 185 (40) 142 (34) 94 (33) Rarely or never 61 (17) 57 (12) 25 (6) 14 (5) Encourage others to follow ICMJE guidelines N = 609 N = 598 N = 495 N = 341 Yes 332 (55) 426 (71) 401 (81) 276 (81) No 277 (45) 172 (29) 94 (19) 65 (19)
Table 3. Experience of and practice in requesting acknowledgment
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■ 2005 ■ 2008 ■ 2011 ■ 2014
100
cause and effect, the evidence can be used 80 to generate hypotheses that merit further evaluation and that might have practical 60 implications. For example, a recent survey25 indicates that the Certified Medical 40 Publication Professional (CMPP) credential is a surrogate marker for broader and more Participants –Participants % 20 current knowledge of medical publication guidelines. This is not surprising because medical writers would be expected to be 0 AMWA EMWA GPP ICMJE aware of guidelines if they had invested in Guidelines the certification examination, achieved a passing score, and maintained the cred - Figure 2. Increased familiarity with guidelines across survey yearsa ential. If future research confirms that a Survey question: “Are you familiar with the content of the following guidelines? certification and other variables are Check all that apply.” associated with transparency and other types of ethical behavior, then employers, were granted. substantial and, for example, were limited to contractors, and authors could use these It is intriguing that writers who con - copy editing. As such, those contributions findings to enhance their criteria for tributed to larger numbers of manuscripts may have been less deserving of ack now - selecting medical writers. In addition, these were more likely to have undisclosed ledgement than more substantial contrib - findings may inspire companies to contributions than less prolific writers. This utions and perhaps may not have met the encourage or even require their writers to explains why the weighted proportion of traditional definition of ghostwriting. Sub- take advantage of educational opportunities undisclosed contributions was slightly stantial contribution, however, is undefined and to audit freelance writers for awareness higher than the unweighted proportion, as in most guidelines, so inter pretation can of and compliance with best practices.26 participants’ responses were weighted in often be a grey area. Alternatively, con - Our findings have additional implic at - proportion to the number of manuscripts. It tributing to larger numbers of manuscripts ions for different stakeholders. Professional is possible that some contributions made by may indeed be correlated with ghostwriting. organisations should escalate their efforts to prolific writers contributing were not While our survey findings do not prove educate members about the dangers of
Variable 2005 2008 2011 2014 PE (95% CI) P value PE (95% CI) P value PE (95% CI) P value PE (95% CI) P value >10 papers/yearb 11.4 (2.2 to 20.5) 0.02 9.6 (-0.6 to 19.7) 0.06 26.2 (16.4 to 36.1) <0.001 23.9 (10.5 to 37.2) <0.001 Mostly reviewsc Not includedd NA 14.1 (5.0 to 23.1) 0.002 12.0 (2.2 to 21.8) 0.02 Not included NA Freelancee 27.8 (17.6 to 38.0) <0.001 14.9 (3.2 to 26.6) 0.01 5.3 (-4.3 to 15.0) 0.28 10.0 (-1.7 to 21.7) 0.09 Familiarity with the following guideline AMWA Not included NA -8.8 (-16.0 to -1.6) 0.02 Not included NA -8.7 (-16.9 to -0.5) 0.04 EMWA -8.2 (-15.0 to -1.4) 0.02 -6.5 (-13.4 to 0.4) 0.07 -7.5 (-13.6 to -1.5) 0.02 Not included NA GPP Not included NA -14.0 (-21.6 to -6.4) <0.001 Not included NA -18.4 (-27.2 to -9.6) <0.001 ICMJE -14.0 (-20.4 to -7.6) <0.001 -17.1 (-24.7 to -9.5) <0.001 -15.7 (-23.6 to -7.9) <0.001 -20.5 (-31.5 to -9.4) <0.001 PhRMA -7.3 (-14.4 to -0.1) <0.05 Not included NA -15.4 (-21.8 to -9.0) <0.001 Not included NA
NA, not applicable; PE, probability estimate, where positive values indicate the variable is associated with ghostwriting and negative values indicate the variable is associated with disclosure. a P < 0.05 in at least two surveys. b Relative to one to two papers/year. c Relative to contributions to manuscripts conveying original data; this question was not included in the 2005 survey. d Not included in multivariate analysis usually because not significant (P > 0.1) in univariate analysis (see footnote c). e Employment type with hospital, university, or medical school as the reference value.
Table 4. Stepwise multivariate linear regression analysisa
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ghostwriting and other unethical practices substantial contributions to manuscripts is prevalence of ghostwriting. that can damage the entire profession and unknown; however, 26.8% (108/403) of Another limitation is the deliberate can embroil authors and funders in AMWA members reported that their avoidance of the word “ghostwriting”, which controversy and potential legal action. primary area of work was scientific was excluded from the survey invitation to Members should commit to lifelong publications in a recent survey (data on file). prevent being trapped by email security learning practices as guidelines are likely to If this proportion is generalisable to EMWA filters. Another reason for avoiding this continue evolving. Medical writers who and is extrapolated to the entire sample, word was an attempt to prevent confusion refuse to ghostwrite can take heart in then 1518 medical communicators (5664 x because the term is frequently misunder - knowing that their requests for acknow - 26.8%) were eligible for our survey in 2014. stood and potentially ambiguous. Unfort - ledgment are likely to be granted. This estimate suggests a participation rate of unately, these efforts necessitated the use of Our findings should not be generalised to 28.8% (437/1518 x 100%), which is better lengthy, often awkward wording, which the overall prevalence of ghostwriting in the than the rate derived from the entire might have led to unintended answers to medical literature because survey particip- membership of AMWA and EMWA (see survey questions about the prevalence of ation was restricted to AMWA and EMWA Table 1). The large decrease between 2005 ghostwriting. At the same time, our survey members who had made substantial and 2008 is probably due to clarification of included questions designed to identify contributions to manuscripts. Although the the survey invitation to better define target inconsistent responses; fewer than 2% of proportion of this subset to the overall participants. We cannot explain further participants were eliminated because of prevalence is unknown, we can make an decreases in response rates in 2011 and invalid responses. estimate based on another survey in which 2014. The number of participants probably medical writing assistance was declared in would have been higher if ISMPP members Author comments 6% of publications in 1000 high-ranking had been invited, but our first survey Our survey findings are bittersweet. The journals.27 If we assume that medical writers predated that organisation. To maintain 44% decrease in the rate of manuscripts with do not disclose one-third of their con - consistency and allow for comparison across undisclosed contributions between 2005 tributions and that the ratio of undisclosed survey years, we did not invite ISMPP to and 2014 is encouraging, but the 34% rate to disclosed contributions is therefore 1:2, participate in subsequent surveys. As the of ghostwriting remains unacceptably high. then the combined findings from our survey survey was anonymous, we do not know Furthermore, the failure to sustain the and the previous survey27 suggest an overall how many respondents in more recent improvement seen in the first three surveys ghostwriting prevalence of approximately surveys had also participated in previous is not only disappointing but also per - 3% (9% – 6%). This estimate, however, surveys. Therefore, it is not possible to know plexing. Clearly, there is no room for should be interpreted with caution because whether the observed decrease in ghost - complacency. We challenge our medical it is based on data from different sources. On writing represents individual writers writer colleagues and professional organ - the other hand, this estimate is closer to that changing their practices, a new cohort of isations to intensify collaborative efforts to reported in previous, well-designed, serial writers who are less likely to make promote transparency and to conduct surveys of authors who had published in six undisclosed contributions than writers research about how to achieve best practices prestigious, peer-reviewed journals; the working in earlier years, or a combination of in medical publication. prevalence was 1.4% in 1996 and 0.16% in both. 2008.28,29 Another limitation is that data were self- Our survey had additional limitations. reported and based on recall. As such, The most important limitation is the participants familiar with ethical guidelines References potential for selection bias of both may have been tempted to answer survey 1. Rennie D, Flanagin A. Authorship! participants (e.g., self-selection) and their questions in way suggesting ethical Authorship! Guests, ghosts, grafters, survey responses. Although respectable for practices, or participants may have forgotten and the two-sided coin. JAMA. an email survey without incentives, our times when they did not observe ethical 1994;271(6):469-471. response rate was low enough that practices. It is possible that AMWA and 2. Sharp D. A ghostly crew. Lancet. participants might not be representative of EMWA members are more likely to follow 1998;351(9109):1076. all AMWA and EMWA members, who in guidelines than medical writers who are not 3. Smith R. Beyond conflict of interest. turn might not be representative of all members of these organisations and that Transparency is the key. BMJ. medical writers. The low response rate is those who devote time to survey part ic - 1998;317(7154):291-292. partly attributable to the previously ipation are also more likely to devote time 4. Lanier WL. Bidirectional conflicts of mentioned restriction to a subset of AMWA to learning ethical guidelines and complying interest involving industry and medical and EMWA members. The proportion of with them. These hypotheses suggest that journals: who will champion integrity? AMWA and EMWA members who make our results might underestimate the Mayo Clin Proc. 2009;84(9):771-775.
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5. Foote MA, Hamilton C, Royer MG. 14. Royer MG, Hamilton CW. The story 25. Woolley KL, Dickson T, Seth A, Contributions of medical writers to behind the AMWA Task Force on the Stretton S. The Certified Medical scientific publications. AMWA J. Contribution of Medical Writers to Publication Professional (CMPP) 2002;17(4):48. Scientific Publications. AMWA J. credential: more than a knowledge test? 6. Jacobs A, Wager E. European Medical 2002;17(3):5-6. (poster 30). 11th Annual Meeting of Writers Association (EMWA) 15. Hamilton CW, Royer MG. AMWA the International Society for Medical guidelines on the role of medical writers Position Statement on the Contributions Publication Professionals. Arlington, in developing peer-reviewed of Medical Writers to Scientific Pub lic - VA; 2015. publications. Curr Med Res Opin. ations. AMWA J. 2003;18(1):13-15. 26. Woolley KL, Feeny S, Ralston J, 2005;21(2):317-321. 16. Stretton S. Systematic review on the Marchington J, Palmisano SM, 7. Battisti WP, Wager E, Baltzer L, et al. primary and secondary reporting of the McMurray B. For the greater good... Good Publication Practice for prevalence of ghostwriting in the medical Can agency competitors cooperate to Communicating Company-Sponsored literature. BMJ Open. 2014;4(7):e004777. advance medical publication practices? Medical Research: GPP3. Ann Intern 17. Hamilton CW, Jacobs A. Survey of Med Writing. 2015;24(3):124-127. Med. 2015:epub ahead of print. AMWA and EMWA members who 27. Woolley KL, Ely JA, Woolley MJ, et al. 8. Huth EJ, Case K. The URM: twenty- make substantial contributions to Declaration of medical writing five years old. Science Editor. manuscripts (abstract 3). AMWA assistance in international peer- 2004;27(1):17-21. Journal. 2006;21(2):50. reviewed publications. JAMA. 9. International Committee of Medical 18. Jacobs A, Hamilton CW. Decreased 2006;296(8):932-934. Journal Editors. Uniform Requirements evidence of ghostwriting in a 2008 vs 28. Flanagin A, Carey LA, Fontanarosa PB, for Manuscripts Submitted to 2005 survey of medical writers. Write et al. Prevalence of articles with Biomedical Journals: writing and Stuff. 2009;18(2):118-123. honorary authors and ghost authors in editing for biomedical publication. 19. Hamilton CW, Jacobs A. Evidence of peer-reviewed medical journals. JAMA. 2006. http://www.icmje.org/ decreased ghostwriting in a series of 1998;280(3):222-224. recommendations/archives/2006_urm. three surveys of medical 29. Wislar JS, Flanagin A, Fontanarosa PB, pdf. Accessed August 21, 2015. communicators conducted between DeAngelis CD. Honorary and ghost 10. International Committee of Medical 2005 and 2011 (abstract). AMWA J. authorship in high impact biomedical Journal Editors. Uniform Requirements 2011;27(3):115. journals: a cross sectional survey. BMJ. for Manuscripts Submitted to 20. Hamilton C, Peña T, Platt M, Gertel A. 2011;343:d6128. See also Web extra Biomedical Journals: writing and Transforming perceptions of medical table 6125 and correction BMJ editing for biomedical publication. writers from coal to diamonds – If 2011;6343:d7677. 2007. http://www.icmje.org/ Superman can do it, so can we! (open recommendations/archives/2007_urm. session 24). American Medical Writers pdf. Accessed August 21, 2015. Association Annual Conference. San Declarations 11. International Committee of Medical Antonio, TX; 2015. Both authors declare that we: 1. have Journal Editors. Uniform Requirements 21. Graf C, Battisti WP, Bridges D, et al. provided or do provide ethical medical for Manuscripts Submitted to Research Methods & Reporting. Good writing services to academic, biotechnology, Biomedical Journals: writing and publication practice for communicating or pharmaceutical clients, 2. have no editing for biomedical publication. company sponsored medical research: financial relationships that may be relevant 2008. http://www.icmje.org/ the GPP2 guidelines. BMJ. to the submitted work; and 3. are active in recommendations/archives/2008_urm. 2009;339:b4330. national and international not-for-profit pdf. Accessed August 21, 2015. 22. Hamilton CW, Hudson S, Gegeny T. associations that encourage ethical medical 12. International Committee of Medical AMWA Code of Ethics added to writing practices. No external sponsors were Journal Editors. Uniform requirements membership application and renewal involved in the preparation of this for manuscripts submitted to forms. AMWA J. 2008;23(4):177-179. manuscript, and no external funding was biomedical journals: writing and 23. Marušić A, Hren D, Mansi B, et al. used. editing for biomedical publication. Five-step authorship framework to 2014. http://www.icmje.org/ improve transparency in disclosing Author information index.html. Accessed Feb 23, 2015. contributors to industry-sponsored A medical writer since 1982, Cindy 13. Pharmaceutical Research and clinical trial publications. BMC Med. Hamilton, PharmD, ELS was President Manufacturers of America. Principles 2014;12:197-206. of AMWA from 2008 to 2009. She has on conduct of clinical trials and 24. Wager E, Woolley K, Adshead V, et al. promoted ethics within the profession communication of clinical trial results. Awareness and enforcement of by developing and leading ethics 2014. http://phrma.org/ sites/default/ guidelines for publishing industry- workshops, conducting research, and files/pdf/042009_clinical_trial_ sponsored medical research among being a founding member of the Global principles_ final_0.pdf. Accessed Feb publication professionals: the Global Alliance of Pub lic ation Professionals 23, 2015. Publication Survey. BMJ Open. (GAPP; www.gappteam.org). 2014;4(4):e004780.
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Supplementary Material Survey Instrument 1. Do you contribute substantially to the writing or editing of 8. How often is your request granted for acknowledgment of your sub - manuscripts prepared on behalf of authors and intended for stantial contributions to manuscripts submitted to medical journals? submission to medical journals? ■ yes ■ no ■ always ■ usually [If the answer to question 1 is yes, the participant will be routed to question 2. ■ rarely or never If the answer is no, the participant will be routed to question 14.] 9. Do you disclose your pertinent professional or financial relationships 2. During an average year, to how many manuscripts intended for (e.g., receipt of funding from a manufacturer or other organisation submission to medical journals do you make substantial associated with the product mentioned in the manuscript) when you contributions? _____ (1, 2, 3 0. 0. 0. >20) are acknowledged for substantial contributions to manuscripts submitted to medical journals? 3. In the last year, what percentage of manuscripts submitted for ■ always publication did not contain disclosure of your substantial ■ usually contribution as a medical writer or editor, either in a byline, as an ■ rarely or never author, or in an acknowledgment? _____% (0% – 100%, increments [If the answer to question 9 is always or usually, the participant will be of 10) routed to question 10. If the answer is rarely or never, the participant will be routed to question 11.] 4. In your experience, how has the frequency of undisclosed substantial contributions changed during the last 5 years? 10. How often is your request granted for disclosure of your professional ■ decreased to none or financial relationships? ■ ■ decreased but still occurs always ■ ■ no change usually ■ ■ increased rarely or never 11. During an average year, how many of your manuscripts convey 5. Are you familiar with the content of the following guidelines? original data?a American Medical Writers Association’s (AMWA’s) Position ■ Most manuscripts convey original data. Statement (www.amwa.org) ■ Most manuscripts are review-like articles. ■ yes ■ no ■ Manuscripts are approximately evenly divided between original European Medical Writers Association’s (EMWA’s) Guidelines data and review-like articles. (www.emwa.org/Mum/EMWAguidelines.pdf) ■ ■ yes no 12. By what kind of organisation are you employed? (Select only one.) Good Publication Practice (GPP) for Pharmaceutical Companies ■ medical communication, medical education, or public relations (http://www.gpp-guidelines.org/) ■ ■ company yes no ■ contract research organisation (CRO) ICMJE Uniform Requirements (www.icmje.org) ■ ■ ■ hospital, university, or medical school yes no ■ journal office or publisher PhRMA’s Guidelines ■ pharmaceutical, biotech, or medical device company (http://www.phrma.org/publications/publications/2004-06- ■ professional society or association 30.1035.pdf) ■ ■ ■ self-employed or freelance yes no ■ other ______
6. Do you encourage authors and other contributors to follow these 13. How many years have you been employed in medical guidelines? communication? (Insert the number of years as a whole numeric ■ ■ AMWA’s Position Statement yes no value, not as a fraction or decimal.) _____ years EMWA’s Guidelines ■ yes ■ no GPP for Pharmaceutical Companies ■ yes ■ no 14. To which organisations do you belong? (Check all that apply.) ICMJE’s Uniform Requirements ■ yes ■ no ■ American Medical Writers Association (AMWA) PhRMA’s Guidelines ■ yes ■ no ■ Board of Editors in the Life Sciences (BELS) ■ Council of Science Editors (CSE) 7. Do you request acknowledgment when you make substantial ■ Drug Information Association (DIA) contributions to manuscripts submitted to medical journals? ■ European Medical Writers Association (EMWA) ■ always ■ International Society for Medical Publication Professionals ■ usually (ISMPP) ■ rarely or never, but I am not opposed to the practice ■ National Association of Science Writers (NASW) ■ rarely or never, because I am opposed to the practice ■ Other (please specify)______[If the answer to question 7 is always or usually, the participant will be routed to question 8. If the answer is rarely or never, the participant will be 15. Please use the space below to add comments and to elaborate on any routed to question 9.] of your answers to this questionnaire. a Question 11 was added in 2008 (i.e., not included in the 2005 survey).
14 | March 2016 Medical Writing | Volume 25 Number 1 The sun never sets on transparency
Introduction HCPs. Despite this lack of clarity, medical The public continues to be made aware of writers should be aware of the current the financial relationships between industry landscape and should be able to discuss the Kim Pepitone1 and Brian P. Sharkey2 and healthcare practitioners (HCPs) and various aspects of the global transparency 1 Cactus Communications, Trevose, PA, the role that these transactions may play in requirements. USA; creating bias and influencing prescribing 2 Porzio Life Sciences, Morristown, NJ, USA choices. Current best practice guidelines, The US Sunshine Act such as Good Publication Practice 3 Overview (GPP3) and the International Committee In brief, the Sunshine Act requires that Correspondence to: for Medical Journal Editors (ICMJE) applicable manufacturers and group purch - Kim Pepitone criteria for authorship support integrity and asing organisations make public certain Cactus Communications Inc. transparency in the publication of industry- financial relationships between themselves 2 Neshaminy Interplex, Suite 100 sponsored clinical trials’ data.1,2 A HCP- and certain HCPs, known as covered Trevose, PA 19053 USA industry specific transparency law, known as recipients, and teaching hospitals (see Table (267) 332-0051 (ext. 125) the US Federal Sunshine Act, was passed in 1 for a list of terms and definitions). The [email protected] 2010.3 Its main goal is to help reduce granular details of the requirements of the potential conflicts of interest that could Sunshine Act were published in February harm clinical integrity and patient care and 2013 in a document called the Rules for Abstract increase healthcare costs.4 Other countries Implementation.4 According to the Rules The financial relationships between the have followed suit (Figure 1). for Implementation, the financial relation- pharmaceutical and device industries and healthcare practitioners appear freq - Australia uently in the spotlight because of their Japan EFPIA amended potential to create bias and influence (code) (code) (code) prescribing choices. Public disclosure of Denmark these transactions may help patients Greece US Slovakia Australia Portugal Romania Turkey make informed choices about their (law) (law) (code) (law) (law) (law) healthcare practitioners and may help reduce healthcare costs. The US Sun- shine Act, a Federal law that requires 2010 2011 2012 2013 2014 2015 disclosure of transactions between industry and healthcare practitioners, was passed in 2010. Similar disclosure Figure 1. Timeline for passage of transparency laws and codes3,11 The US Sunshine Act, laws and codes now exist globally. Un - passed in 2010, is a transparency law requiring public disclosure of financial fortunately, none of the current require- transactions between the pharmaceutical and device industries and healthcare ments are clear about the reportability of practitioners. Many other countries have followed suit, with either laws or codes. It is industry support for medical writing and anticipated that this trend will continue in 2016 and beyond. editorial services. Regardless, medical writers should be aware of these Unfortunately, the global transparency ships that must be reported can be in the requirements, which can help them as report ing requirements have little detail form of direct payment or TOV, and they forge relationships with authors. about non-monetary support for medical include payment or TOV of 10 USD or writing and editing, and whether or not it more. Employees of sponsoring companies constitutes a transfer of value (TOV) to who meet the definition of covered
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Term Definition Applicable manufacturers Manufacturers of covered drugs, devices, biologicals, and medical supplies covered under Medicare, Medicaid, or the Children’s Health Insurance Program Group purchasing An entity that helps healthcare providers, such as hospitals, nursing homes and home health agencies, save money organisations by purchasing large volumes and use that as leverage to negotiate discounts with manufacturers, distributors and other vendors. Covered recipients Licensed medical doctors, doctors of osteopathy, dentists, optometrists, podiatrists, and chiropractors Teaching hospitals All hospitals that receive direct or indirect graduate medical education payments from Medicare Transfer of value (TOV) Anything of value given by an applicable manufacturer or group purchasing organisation to a covered recipient or physician owner/investor that does not fall within one of the excluded categories under the Sunshine Act Rules for Implementation Healthcare organisations A legal person whose business address, place of incorporation, or primary place of operation is in Europe that is (HCO) involved in the provision of healthcare services (e.g., hospital, learned society, association of HCPs). Healthcare provider (HCP) Any licensed healthcare practitioner who provides patient care
Table 1. Specific terms and definitions related to the Sunshine Act recipient are excluded. “There were ~ the reporting requirements. patients. The Centers for Medicare and The public database that 11 million hits For example, the exemption Medicaid Services did not agree, and contains the financial for reporting payment to declined to change the classification of these transaction data is known within the first 24 hours physician speakers at accred - items.8 There continues to be widespread as Open Payments, and is following release of the ited or certified continuing disagreement with the decision made by the administered by the US first Open medical education (CME) Centers for Medicare and Medicaid. Centers for Medicare and Payments data set” events was deleted.7 Accord- In July of 2015, the US House of Medicaid Services. The ing to the Centers for Medi- Representatives overwhelmingly voted in first financial transaction care and Medicaid Services, favour of the 21st Century Cures Act.9 The data were released on September 30, 2014, this was done to create consistency in the major purpose of this act is to increase the and within 24 hours, there were reportedly reporting of payments to speakers at certain speed with which new medicines reach 11 million hits.5 On October 1, 2015, the accredited or certified CME events, and to patients. It also includes a provision to BMJ released a feature article detailing the give clarity to consumers who will ultim - exempt certified CME events and the types of payments made, the top five ately have access to the reported data. Thus: acceptance medical texts and journal companies making payments, the top five “Starting in 2016, when an applicable reprints by covered recipients from drugs to which payments were attributed, manufacturer provides an indirect Sunshine reporting. The proposed changes and the five most highly paid physicians. payment or other [TOV] to a continuing to the Rules for Implementation include the The article also included the following education organization for a continuing following: quote from a 2014 article published in the education event to physicians, and knows “In the case of a [covered recipient] who Annals of Internal Medicine: 6 or finds out the identity of the physician is a physician, an indirect payment or “One may presume that the public may attendees/speakers within the reporting TOV to the [covered recipient] for have difficulty distinguishing between year or by the end of the second quarter speaking at, or preparing educational donated drugs for research and transfers of the following reporting year, that materials for, an educational event for of financial value to physicians. Such payment must be reported to the Centers physicians or other health care profess- confusion frustrates the purpose of [the for Medicare and Medicaid Services in ionals that does not commercially Act], casting shadows where bright light 2017.” promote a covered drug, had been promised.” Under the Rules for Imp - device, biol ogical, or And in fact, this may be the case. For lementation, reprints and text - “It is unclear as to medical supply” [would be example, the reporting of funding for a books provided by applicable whether the US Senate exempt from reporting clinical trial, which would likely include manufacturers to covered will address proposed under the Act]. administrative costs for conducting the recipients is a reportable Sunshine Act The US Senate has trial as well as the cost of the drug, might TOV.4 In November 2013, 23 declined to vote on the bill be recorded in the database as a large members of the US House of exemptations for as a single entity. Instead, payment made to an individual physician Representatives commun ic - reprints and they are addressing the investigator. ated their disagreement to the textbooks.” legislation as smaller, Centers for Medicare and individual bills. It is unclear Updates and Changes to the Sunshine Act Medicaid Services regarding at this time whether they Since the initial publication of the Rules for classification of these items as a reportable will address the above-mentioned proposed Implementation in February 2013, we have TOV, as this type of information promotes Sunshine Act exemptions for reprints and seen some changes intended to help clarify good medical care and, ultimately, supports textbooks.
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In October 2015, the US Senate hensive law was enacted in France in portal, and the information is made proposed legislation that would broaden the December 2011, LOI n 2011-2012 du 29 publicly available on a govern mental Sunshine Act to include the reporting of décembre 2011 relative au renforcement de la website (www.transparence.sante.gouv. financial transactions between applicable sécurité sanitaire du médicament et des fr). manufacturers and physician assistants, produits de santé, also known as the French Initially, only the existence of an nurse practitioners, and other advanced Act.11 The French Act, and its implement - agreement – but not the amount – had to be practice nurses, all of whom are licensed to ing decrees, requires broad disclosure by reported. An update is now pending that will prescribe covered products.10 If passed, pharmaceutical and medical device require details on the amount of payment to reporting for this expanded group of companies of agreements with and benefits be reported. covered recipients would begin in 2017. provided to HCPs and various entities. Under the French Act, there are two main Beyond France: Laws and Codes Global Transparency types of disclosure require ments: A number of other European countries have Focus on France 1. All agreements, except for commercial introduced laws requiring or codes recomm - Other countries and regions of the world sales agreements of goods and services, ending reporting requirements (Figure 1). have joined the transparency movement. that companies have with specified 11 It is important to understand the Europe has experienced the most activity on individuals, inc luding HCPs, and entities, distinction between the two: laws are the transparency front, but it has also must be reported within 15 days of governmental or legislative requirements extended to places like Australia and Japan. signing; where as codes are only binding on comp - Unlike the US, where transparency report- 2. Certain benefits given to those indiv - anies that are members of the particular ing requirements have been established in iduals and entities, must be industry group. For example, Federal and State laws, in Europe the reported biannually. “It is important to in Denmark, pharmaceutical transparency requirements have been Companies must report understand the and medical device created either by governments through laws the required information companies are required by law and regulations or by self-regulatory bodies about benefits and distinction between to report certain details about in the form of voluntary industry codes. agreements to the French transparency laws and their relationships with HCPs The first, best-known, and most compre- government via a web transparency codes.” but not the amounts paid.
HCPs: City of Principal Practice Country of Principal Principal Practice Unique country Fee for service and consultancy (Art. 3.01.1.c Full Name Contribution to costs of Events (Art. 3.01.1.b & 3.01.2.a) HCOs: city where Practice Address identifier OPTIONAL & 3.01.2.c) registered
Donations and Grants TOTAL to HCOs (Art. Related expenses agreed in the fee for OPTIONAL 3.01.1.a) Sponsorship service or consultancy agreements with Travel & contract, including (Art. 1.01) (Art. 3) (Schedule 1) (Art. 3) (Art. 3) HCOs / third parties Registration Fees Fees Accommodation travel & appointed by HCOs to accommodation manage an Event relevant to the contract
INDIVIDUAL NAMED DISCLOSURE - one line per HCP (i.e. all transfers of value during a year for an individual HCP will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate)
Dr A N/A N/A Yearly amount Yearly amount Yearly amount Yearly amount Dr B N/A N/A Yearly amount Yearly amount Yearly amount Yearly amount etc. N/A N/A Yearly amount Yearly amount Yearly amount Yearly amount OTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasons HCPs Aggregate amount attributable to transfers of value to such Recipients - Art. 3.02 N/A N/A Aggregate HCPs Aggregate HCPs Aggregate HCPs Aggregate HCPs Optional Number of Recipients in aggregate disclosure - Art. 3.02 N/A N/A number number number number Optional % of the number of Recipients included in the aggregate disclosure in the total number of Recipients N/A N/A % % % % N/A disclosed - Art. 3.02
INDIVIDUAL NAMED DISCLOSURE - one line per HCO (i.e. all transfers of value during a year for an individual HCO will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate)
HCO 1 Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Optional HCO 2 Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Optional etc. Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Yearly amount Optional OTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasons HCOs Aggregate amount attributable to transfers of value to such Recipients - Art. 3.02 Aggregate HCOs Aggregate HCOs Aggregate HCOs Aggregate HCOs Aggregate HCOs Aggregate HCOs Optional Number of Recipients in aggregate disclosure - Art. 3.02 number number number number number number Optional % of the number of Recipients included in the aggregate disclosure in the total number of Recipients %%%%%% N/A disclosed - Art. 3.02
AGGREGATE DISCLOSURE
R &D Transfers of Value re Research & Development as defined - Article 3.04 and Schedule 1 TOTAL AMOUNT OPTIONAL
Figure 2. An example of the EFPIA template for reporting TOV. Source: http://transparency.efpia.eu/
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Instead, it is the Danish HCPs that must aggressive approach to transparency, English. The EFPIA provides a reporting report such financial support. Portuguese Eucomed, which represents the medical template that lists the types of data that law requires companies to report support device industry in Europe, has chosen to not companies must disclose. (see Figure 2 for and sponsorship provided to HCPs that impose reporting require ments on its example of the template). exceeds € 60. Other European countries members. with financial transparency reporting laws Under EFPIA’s Disclosure Code, the first Individual vs aggregate reporting include Slovakia, Romania, Greece, and year of data collection was 2015, and first Although EFPIA wants as much individual- Turkey. In the Pacific Rim, industry groups reports are due in 2016. The Code includes level report ing as possible, there are two in Japan and Australia have also introduced three individual-level categories for instances in which companies will report at code-based transparency requirements. companies to report their direct payments the aggregate level.12 Although the specifics of the requirements and TOV provided to HCPs and HCOs 1. When legal reasons prevent certain may differ by individual country, the (Table 2).13 information from being disclosed. The message is clear: global transparency is here. According to EFPIA’s Disclosure Code, Disclosure Code is not a law and is disclosures must be made on an annual superseded by data privacy laws, so EFPIA: Industry driven basis, with each reporting period covering a companies must obtain the consent of a approach to transparency full calendar year. Companies must make recipient to publicly disclose individual The European pharmaceutical industry has their disclosure within 6 months of the end information. If consent is not provided, been proactive in seeking to develop and of the preceding reporting period, and the individual-level data cannot be reported. implement an industry-driven approach to disclosed information must remain in the 2. Research and development. This transparency. This effort has been led by the public domain for 3 years, unless local laws includes TOV to HCPs or HCOs for the European Federation of Pharmaceutical require a shorter time or a recipient planning or conduct of clinical trials or Industries and Associations (EFPIA), which withdraws his or her previously granted non-interventional studies that involve includes 33 national member associations consent relating to a specific disclosure. the collection of patient data from or on and 40 corporate members. The EFPIA Companies must document all payments behalf of individual, or groups of, HCPs adopted a Disclosure Code in June 2013, and TOV required by the code and maintain specifically for the study. which was slightly amended in 2014. The records for at least 5 years, unless local law For instances in which legal reasons EFPIA Disclosure Code requires individual- requires a shorter period. prevent individual-level disclosure, for each level reporting of TOVs to HCPs and The Disclosure Code provides two reported category, the aggregate disclosure healthcare organisations (HCOs) by its options for disclosure: 1. on the reporting must identify the number of recipients members.12 company’s website; or 2. on a covered by the disclosure (on both an EFPIA’s goal in adopting “The goal of EFPIA’s central platform, which can be absolute basis and as a percentage of all its Disclosure Code was to Disclosure Code is developed by the national recipients) and the aggregate amount attrib - create a uniform approach to to create a uniform member association. The dis - utable to the TOV. In contrast, when transparency reporting across closures must be made in the companies report research and development Europe for the pharmaceutical approach to local language, although TOV at the aggregate level, they simply industry. In contrast to the transparency across companies are encouraged to disclose a single monetary figure that en - pharmaceutical industry’s Europe.” also make the disclosures in compasses all such transfers in a jurisdiction,
Category Description 1 Donations and grants (HCOs only) 2 Contributions to costs related to events, including registration fees; travel and accommodation, to the extent permissible; and, for HCOs only, sponsorship agreements with HCOs or with third parties appointed by an HCO to manage an event 3 Fees for service and consultancy. In contrast to the US, companies do not have to report the details of every single transaction that they have with a HCP or HCO; instead, they are permitted to aggregate all their TOV to a HCP or HCO on a category- by-category basis Exclusions 1. Transfers that are solely related to over-the-counter medicines 2. Transfers that are not explicitly identified in the Code, including, for example, items of medical utility, meals/drinks, and medical samples 3. Transfers that are part of ordinary course purchases and sales of medicinal products by and between a member company and a HCP or HCO Table 2. EFPIA Disclosure Code Reporting Categories
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without having to provide any accomp - reports or having companies place their Questions document issued by EFPIA does anying details. reports on their own corporate websites. address the topic, although the comments are Most national member associat ions have somewhat ambiguous.13 Accordingly, comp- Bringing EFPIA home chosen to have companies simply place the anies will have to determine whether and how The Disclosure Code requires EFPIA’s reports on their websites instead of creating they report TOV associated with medical national member associations to integrate a central registry. writing and editorial support, and they will the disclosure requirements into their own have an opportunity to publicly explain their national codes, except when the reporting Global Sunshine and medical rationale for their decisions. The Disclosure requirements are inconsistent with national writing: what do we know? Code requires companies to publicly disclose laws or regulations.12 Such inconsistencies One area of the Sunshine Act that continues a note that summarises the methodologies exist in France, Denmark, and Portugal. In to lack clarity is whether providing non- they used to prepare their disclosures and to these cases, EFPIA permits deviations from monetary medical writing and editorial identify TOV for each category.12 Although the Disclosure Code, so that companies are support constitutes a TOV. Interpretation of companies are not obligated to address how not required to report under both the the Rules for Implementation has varied they treated medical writing and editorial governing law and a national industry code. between industry companies, with some support in their methodology notes, they can EFPIA’s approach to transparency should reporting it as a TOV and others not explain their decision and rationale. As with produce some consistency across Europe, (Table 3).14 the US, this lack of clarity may likely lead to although it is impossible to achieve absolute As noted by Toroser and colleagues, we incon sistencies among companies and could consistency for two main reasons. First, the still lack definitive guidance in this area.15 lead to confusion among authors who work various national disclosure laws, which may The support provided to covered recipient with different companies.17 There could also have different reporting requirements, take authors is intended to ensure that applicable be a chilling effect on industry-HCP relation - precedence over industry’s self-regulatory manufacturers can meet their ethical ships.15,17 The potential negative impact may approach. Second, although EFPIA’s member obligations to publish clinical trial data in as be in the form of investigators declining to associations have almost uniformly adopted timely a manner as possible. This benefits work with industry on clinical trials and the categories of TOV that must be reported the applicable manufacturer. Ascribing TOV clinicians declining to participate as authors at the individual or aggregate levels, some to this support for an author could under- of clinical-trial publications. The latter have taken slightly different approaches to mine the credibility of the authors, the study example may lead to the loss of critical real- some issues. For example, a handful of sponsor, and the results of the research, world clinical-practice interpretation of jurisdictions, including Spain, the Nether- because the support may be misconstrued clinical trial results, which could, ultimately, lands, and Belgium, require companies to as payment for authorship.16 harm patient care. disclose a unique country Similar to the US experience identifier for each recipient on Medical writers with the Sunshine Act, the Disclaimer their reports. As noted need to know the EFPIA Disclosure Code does The opinions expressed herein are those of previously, under the Dis clo s - nuances around the not explicitly address the report - the authors and do not necessarily reflect ure Code national assoc iations reportability of non- ability of TOV assoc iated with the opinions of their employers. The authors have the option of either monetary medical medical writing and editorial have no financial conflicts of interest to creating a central registry for writing support.” support. A Frequently Asked declare.
No, the support does not need Yes, the support must Maybe to be reported be reported Whether the support needs to be reported depends on the The support is of value to applicable The support is of value to the circumstances. For example, there is no TOV for clinical study manufacturers because it helps them covered recipient authors manuscripts, but there is a TOV for authors who request meet their ethical obligations to because they would have had to support from the applicable manufacturer for publication of publish their data in as timely a either do the work or pay for the data from an investigator-initiated study. manner as possible. In this case, the support had the applicable support is of no value to the covered manufacturer not provided the Source: International Society for Medical Publication recipient authors. support. Professionals14
Table 3. Reporting Scenarios for Publication Support Under the Sunshine Act
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References 8. Andrews RE, Schwartz AY, Meehan P, 15. Toroser D, DeTora L, Cairns A, et al. 1. Battisti WP, Wager E, Baltzer L, et al. et al. Final Sunshine Act letter to The Sunshine Act and medical Good Publication Practice for Marilyn Tavenner. 2014. publications: Guidance from Communicating Company-Sponsored 9. Upton F. HR6-21st century cures act. professional medical associations. Medical Research: GPP3Good 2015. Postgrad Med. 2015/11/04 Publication Practice for Company- 10. Grassley C. S.213-Provider Payment 2015;127(7):752-757. Sponsored Research (GPP3). Annals of Sunshine Act. 2015. 16. Wechsler R, Hauser RA, French J, Internal Medicine. 2015;163(6): 11. Campbell DJ, Sharkey BP. Ready or the Clinician Investigator C. Who is 461-464. not, full speed ahead for the global helping whom? Manuscript support 2. ICMJE. Recommend at ions for the transparency movement. 2015; and transfer of value. Annals of conduct, reporting, editing, and http://porziolifesciences.com/ Neurology. 2015;77(2):353-355. publication of scholarly work in medical resources/publications. 17. Ratain MJ. Forecasting unanticipated journals. 2013; www.ICMJE.org 12. European Federation of Pharma ceut - consequences of “the Sunshine Act”: 3. United States 111 Congress HR 3590. ical Industries and Associations. EFPIA mostly cloudy. JCO. 2014;32(22): Patient protection and affordable care HCP/HCO disclosure code. 2014:1- 2293-2295. act. 2010:111-148. 15. 4. Centers for Medicare and Medicaid 13. European Federation of Services. Federal register. Department Pharmaceutical Industries and of Health and Human Services; Associations. EFPIA code on disclosure 2013:9457-9528. of transfers of value from pharma - Author Information 5. Jarvies D, Coombes R, Stahl-Timmins ceutical companies to healthcare Kim Pepitone, CMPP, is a Scientific W. Open Payments goes live with professionals and healthcare Director at Cactus Communications, pharma to doctor fee data: first analysis. organisations: Frequently asked specialising in education about good BMJ (Clinical research ed.). 2014-10- questions. 2014; http://transparency. publication practices. Ms Pepitone is the 01 16:46:40 2014;349. efpia.eu/countries/download/11/ Vice Chair of the ISMPP Sunshine Act 6 Morain SR, Flexner C, Kass NE, document_2/faq–disclosure-code.pdf. Task Force. She has published and Sugarman J. Forecast for the Physician Accessed November 22, 2015. lectures frequently on the topic. Brian P. Payment Sunshine Act: Partly to Mostly 14. The International Society for Medical Sharkey is Vice President of Porzio Life Cloudy?Forecast for the Physician Publication Professionals. ISMPP Sciences, a subsidiary of the law firm Payment Sunshine Act. Annals of Sunshine Act information update. Porzio, Bromberg & Newman, where he Internal Medicine. 2014;161(12): 2014; http://www.ismpp.org/assets/ specialises in counselling life sciences 915-916. docs/Inititives/Sunshine_Act/sunshine companies on a variety of compliance- 7. Centers for Medicare and Medicaid %20act%20interpretation%20update_ related issues, most significantly those Services. CMS implements final rule february%202014_final.pdf. Accessed relating to ex-US marketing disclosure, change for open payments. In: Services November 22, 2015. gift limitation laws, and industry codes. CfMaM, ed. Vol Pubilc law no. 111- Mr. Sharkey is also an attorney with 152: Centers for Medicare and Porzio, Bromberg & Newman. Medicaid Services; 2014.
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Keith Veitch writers have continued to become more protocol to regulatory submission. The keithveitch communications specialised over the past two decades, as simple view was that scientists would run Amsterdam, The Netherlands reflected in the specific training certificates their experiments and publish the data, offered by the EMWA Professional driven by the need of academics to have Development Prog ramme. papers to secure tenure and further grants, Correspondence to: Most facets of medical writing have and by the need for industry to promote [email protected] always been regulated by legislation, and their products. The interface between the training can be focussed on meeting those two was a grey area that few understood and needs. However, one area where it has been most never questioned. However, as Abstract assumed that training is not needed is that negative headlines about the pharmaceutical The good publication practice for of medical communications, namely, industry became increasingly frequent, pharmaceutical companies (GPP) manuscripts for peer-reviewed journals, public trust rapidly dissipated, leading to guidelines were first published in 2003, abstracts, posters, and slide presentations for increasing demands from many stakeholders then revised in 2009 (GPP2) and most conferences. The prevailing belief is medical to increase and enforce data dissemination recently in 2015 (GPP3). The latest writers learn how to write these documents and transpar ency for industry-sponsored version reflects the changes that have during their university education through clinical trials. occurred in legislation concerning expertise passed on by their PhD or Master’s dissemination of data from clinical trials, supervisor, who in turn had learned from Regulation of publications mainly focussed on the pharmaceutical their peers. This belief persists in academia, The result of demands for increased data industry. These guidelines are intended where despite the need to publish the results dissemination and transparency was a to serve as a basis for publication of scientific projects to add to one’s sequential increase in legislated requirements professionals to establish transparent and curriculum vitae or support grant proposals, for public reporting of clinical trials. This ethical working practices within the little or no consideration is given to how pharmaceutical industry. The need for such publications should be such guidance and the main differences written. in the latest version are introduced. The same situation existed in the pharma- ceutical industry in the Background 20th century, with The term Medical Writing encompasses a publication being the wide field of diverse forms of written final un controlled, communication that seemingly only medical unregulated stage of writers themselves can understand and a process that gen- distinguish. The different demands and erated clinical results requirements for writing regulatory docu - through a strictly con- ments, clinical study reports, grant trolled process, from applications, and publications mean that medical writers usually be - come specialised in one or two areas. For example, a writer may have the background, skill set, and familiarity with the legislative requirements to work on both regulatory and clinical documents but may have little or no knowledge about the intricacies of narrative writing or publications. Due to increasing legislation and control in almost all aspects of medical writing, medical
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began with voluntary registration of clinical One of the problems is that industry may GPP2 – 2009 trials on internet sites such as the US-based not always control publication of results The next iteration of GPP – GPP2 – was ClinicalTrials.gov and EudraCT in Europe. from clinical trials that they sponsor. Of published six years later, in 2009.3 GPP2 was Editors of major scientific and medical course, even scientists who do not need a more complete document written by a journals immediately supported these additional publications for their curricula larger author panel (12 vs. 3 in the original requirements and added punctual regist - vitae may still want to publish, but industry- GPP) representing pharmaceutical comp - ration of clinical trials as a criterion for the sponsored clinical trials often involve dozens anies, publishers, communication agencies, acceptance of manuscripts based on clinical of academic investigators, not to mention in- and independent medical writers. Before trials. As companies realised they would no house experts who are equally valid contrib- submission, the guidelines were also longer be able to publish their studies in the utors to the research, so who owns the data reviewed by a wide review panel that top journals without registering their trials, and is therefore responsible for its included representatives from academia and they rapidly accepted this requirement. publication can be unclear. Another journal editors. GPP2 was more compre - When this was followed by the requirement limitation to publishing everything is that hensive than GPP and introduced or to report the results of those trials on the corporate enthusiasm – and therefore supported new concepts, including written same sites, it was also quickly accepted by budget support – to publish relies on the publication agreements, publication steering industry. Currently, the final stage of public novelty or interest in the data, and committees, checklists, and the contributor- disclosure is becoming established, giving something that is not particularly novel or ship model, while reinforcing the authorship qualified researchers access to patient-level beneficial for a product may not obtain the guidelines proposed by the International data from company-sponsored clinical trials resources needed to generate and submit a Committee of Medical Journal Editors through internet sites. manuscript punctually. (ICMJE) and adherence to trial registration This leaves the final form of data sharing, and results posting requirements. the writing and publishing of scientific and Good Publication Practice – As a more detailed document with many medical papers in peer-reviewed journals, as 2003 concepts more precisely covered, GPP2 was the last area for which there is no legislation. It was against this background and the lack ideal for helping publication professionals Publication is still a voluntary exercise – of regulations that a meeting of academics, establish internal guidelines and ways of there is no legal obligation to publish – journal editors, and industry representatives working. Having such externally written driven only by the ethical commitment was organised in 1998 by the Council of guidance also lent credence to the idea that inherent in the International Conference on Biology Editors. The aim was to establish publication professionals brought value to Harmonization (ICH) to make all data clear guidelines and standards for industry- their employers and reinforced the ability of public and in the knowledge that an sponsored biomedical research publications. writers to insist on ethical working practices. unpublished study is a wasted opportunity It took another 5 years for the results of that to demonstrate not only full transparency first meeting to come to fruition, with the GPP3 – 2015 but also the benefits of a product. publication in 2003 of Good publication As with the original guidelines, GPP2 Failure to publish all clinical trial data has practice for pharmaceutical companies resulted in numerous unanswered questions been waved in the face of the industry as (GPP).2 This document was the first to and requests to include more detail and evidence of malpractice. Accusations that provide standards for industry-based additional topics. The most recent version, poor or negative data are being hidden are manuscripts, but it was restricted to a GPP3, published in late 2015, has therefore common. Furthermore, compliance with relatively small set of issues: the obligation continued to build on the original guide - the requirement to register clinical studies to publish everything, the role of lines.4 It focusses on the core values of GPP on ClinicalTrials.gov has exacerbated this professional medical writers in assisting with and GPP2 and also adds further detail and situation. Even though there are manuscripts, and a first brief an improved organisation to enhance clarity many reasons for which a study approach to a major issue for all and eliminate redundancy. Sections already may never be published (e.g. it As manuscripts, authorship. present in GPP2 have been built upon and may never have been con - with the original Although GPP was rapidly updated, taking into account the evolution ducted or was never comp - guidelines, GPP2 taken up by medical writers as of publication and data dissemination leted), industry is being held resulted in numerous guidance within their comp - practices. GPP3 starts with a list of 10 key to account when a paper does unanswered anies, even at its inception it publication principles, which are intended not appear. This ignores the questions and was evident that many topics to support the six core principles of GPP: published evidence that had not been considered and integrity, transparency, completeness, company-sponsored research requests to include that a more comprehensive accuracy, accountability and responsibility. is more widely reported than more detail and guidance document was These 10 principles can also serve as a academic trials.1 additional topics. required. checklist for authors and medical writers.
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Authorship GPP3 also provides recomm - Typical guidance already available for Notable changes in publication practice endations on how they should comments have different types (e.g. PRISMA occurred following revisions to the ICMJE work with authors. A key guidelines for systematic requirements for authorship in 2010 and recommendation is to clearly included “make it for reviews). This section also 2013 (and which have been further revised establish defined roles and academics too!,” covers encore presentations at in December 2015). These include addition responsibilities before writing “send it to different congresses. of a fourth criterion to the original three starts. Also discussed is how universities,” and criteria for authorship:5 the role of the medical writer “maybe the next step Data sharing “Agreement to be accountable for all may, in certain circumstances, for GPP3 could be Important areas of evolution aspects of the work in ensuring that result in authorship. As in since GPP2 have included questions related to the accuracy or GPP2, GPP3 recommends guidelines for non- clinical trial data dissemin - integrity of any part of the work are written agree ments for company-sponsored ation following trial reg ist - appropriately investigated and resolved.” authors, medi cal writers, and medical research?” ration with data posting and Authorship is a grey area that seems to agencies, as well as estab - data sharing with researchers. generate more disputes and problems in lishing public ation stee ring GPP3 recognises and fully manuscript preparation than any other – committees. GPP3 also recomm - endorses all aspects of clinical trial despite the ICMJE criteria and the extensive ends that, for transparency, any writing reporting, while noting that it does not attention it gives to the subject of contribution must be acknowledged along substitute for publication as a means of authorship.5 GPP3 therefore also addresses with the source of funding for such support. presenting and explaining the data in authorship, with the intent of clearly GPP3 supports use of the contributor - context. More importantly, data posting identifying and defining authorship. A ship model of authorship, wherein each does not constitute prior publication, nor specific intention is to eliminate, once and author’s role in the work is clearly defined does it cover the ethical obligation to for all, the practices known as guest and potential conflicts of interest, financial publish, as the researcher has an obligation authorship and ghostwriting. Publication or otherwise, are disclosed, even if the target to present the work in the context of current professionals are aware of these concepts journal does not request such information. knowledge and note the contribution that and avoid them, but having them defined in GPP3 recommends calling such inform - the work makes. GPP3 makes it easier to communicate this ation Disclosures because this term carries no An important point raised in GPP3 is knowledge to colleagues and ensures that negative connotation and is more likely to that any publication of clinical trial data – they are recognised as unacceptable encourage greater disclosure of both abstract, poster or paper – should include practices. financial and non-financial sources of the appropriate trial registration identifier to Another authorship issue that frequently potential conflict of interest. Use of the allow readers to identify the study. This also arises is the question of payment and contributorship model may also identify helps ensure that data are not published in reimbursement of an author’s time for their gaps in contributions that should be covered duplicate, even unintentionally. Having role in manuscript development. GPP3 by the author panel. For example, if no one mentioned duplicate publication, GPP3 provides additional guidance and clarity on is identified as having performed statistical does note that certain exceptions can be this divisive issue – even the authors of analyses, who was responsible for ensuring made for encore presentations of abstracts GPP3 had differing perspectives. Other the accuracy of the data or the appropriate- and posters at scientific congresses in authorship issues, such as author number, ness of the analytical methods employed? different specialties or geographies. Equally, author order, deceased authors, and authors Finally, GPP3 discusses the use of author GPP3 advises that every effort be made to no longer with the company, are specifically groups for large trials. minimise plagiarism, including self- addressed in a table. plagiarism, a concept addressed for the first Types of articles time in GPP3. Role of professional medical writers Noting the impact that data posting may Two common questions for publication have on publications, some guidance is Towards GPP4 professionals are how they justify their role given on appropriate timing. GPP3 GPP3 is just the latest evolution of an in manuscript preparation and why they are establishes the principle that the primary established process. Undoubtedly, there will not then themselves authors? GPP3 publication must be published before be a GPP4, which will take into account attempts to address both questions, notably secondary articles, which themselves must further evolution in the fields of data by presenting published data supporting the clearly identify and refer to the primary dissemination and publication. The timing importance of medical writers in improving article. GPP3 briefly touches on the and content of GPP4 are yet to be the quality of submitted manuscripts. In different types of scientific article that may determined. In the meantime, the GPP3 defining the need for professional writers, be written, with some indication of the Steering Committee acknowledges that
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 23 Veitch – GPP3 – what is it, why is it necessary and what is new?
References 1. Anderson ML, Chiswell K, Peterson ED, et al. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med 2015;372:1031–9. 2. Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003;19(3):149–54. 3. Graf C, Battisti WP, Dan Bridges D, et al. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330. 4. Battisti WP, Wager E, Baltzer L, et al. Good Publication Practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461–4. 5. International Committee of Medical Journal Editors. Recommendations [cited January 5, 2016] Available at: http://www.icmje.org/ recommendations/.
Author information Keith Veitch is a biochemist who moved questions will arise in the interim; so the “send it to universities,” and “maybe the next from research into publication writing, committee, in conjunction with the Inter - step for GPP3 could be guidelines for non- originally with GSK in Belgium, almost national Society for Medical Publication company-sponsored medical research?” 20 years ago. He subsequently headed Professionals (ISMPP), has established an GPP3 is endorsed by an increasingly wide publication groups in Sanofi Pasteur online repository of questions and answers range of organisations concerned with (Lyon, France) and Novartis Vaccines and relevant resources on publication scientific communication and medical (Amsterdam, the Netherlands). He is practice (http://www.ismpp.org/gpp3). writing, including EMWA, the American now a freelance consultant in public - Further questions about GPP3 can be Medical Writers Association, the Comm - ations and medical writing, particularly submitted to its authors at [email protected]. ittee on Publication Ethics, the European for infectious diseases and vaccines. In future, the ISMPP-GPP3 website may Association of Science Editors, and the Keith served in EMWA as President serve not only as a resource but also as a Japan Medical and Scientific Communic - and as Editor of The Write Stuff platform for recruiting new members to the ators Association. Perhaps, with the support (forerunner of Medical Writing). He has GPP team to work on GPP4. of such organisations, GPP4 will become worked with various organisations con - What will GPP4 bring? That remains to the go-to model for all writers of medical cerned with ethical reporting of clinical be seen, but the feedback from reviewers of communications, not only of industry- trials, including ISMPP and TIPPA, and GPP3 and subsequent comments from sponsored studies, for increasing trans - was a member of the Steering Committee users gives a strong hint. Typical comments parency and the quality of clinical trial and author for GPP3. have included “make it for academics too!,” reporting.
24 | March 2016 Medical Writing | Volume 25 Number 1 Commentary Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation: new themes in the ethical critique of commercial medical literature
Alastair Matheson To understand the ethical challenges surr - but attribution per se, considered as the sum Toronto, Canada ounding authorship in industry-financed and balance of all the information comm - medical journal articles, one must look unicated about the article, has received scant beyond authorship alone and examine their attention. The current International Comm- Correspondence to: attribution considered as a whole. I argue in ittee of Medical Journal Editors (ICMJE) [email protected] this essay that the attribution of industry Recommend at ions exceed 13,000 words,4 literature including authorship is routinely but the term “attribution” appears not once. spun for marketing purposes to exaggerate Proper attribution requires clear comm - Abstract the role of academics and downplay that of unication with the reader. It is determined To clarify the ethical difficulties surr- companies. Furthermore, I argue that this not merely by what is documented but also ounding authorship in industry-financed practice is not merely misleading but part of by what is brought to readers’ attention. medical journal articles, one must a pernicious cultural transformation of Proper attribution requires key information consider their overall attribution rather science and medicine that should be resisted to be related fully, in clear language and for than authorship alone. Correctly under - by everyone concerned for scientific the most salient information to be made stood, attribution involves not only integrity. prominent at the head of articles, not buried authorship but everything an article in small print (Table 1). Articles failing to communicates to readers about its Attribution do this may be misattributed if they give a stakeholders, origins, and development. The attribution of journal articles is misleading overall impression of the article’s Proper attribution requires that the most sometimes thought to be synonymous with development. In my experience, this is an important aspects of the origins and authorship, but in fact, everything an article enduring problem in pharma’s journal development of an article are brought relates to readers about its provenance, literature. most prominently to the attention of stakeholders and development should be readers, rather than disclosed in inconsp - considered part of its attribution (Table 1 icuous small print. An important ethical overleaf). Individual aspects of problem arises when, for marketing attribution, such as authorship, reasons, attribution including authorship contributor ship and disclosure, is spun to exaggerate the role of academic have been addressed by recruits and downplay that of the medicine’s editorial community companies themselves. This practice is over the decades,1-4 unethical but consistent with medicine’s current editorial recommend ations. Here, I introduce new themes and con cepts in the ethical analysis of commercial practices, and propose changes to editorial guidelines to ensure that companies, not their contingent academic recruits, are assigned the dominant authorial role in industry-financed journal literature.
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Definition • The sum and balance of everything an article or presentation communicates to its audience about its stakeholders and contributors, their roles and their interests.
Components • Authorship including number of authors and corporate authorship • Author sequence • Contributor listings • Acknowledgements and footnotes • Labeling and advisory statements • Textual descriptions of stakeholder roles • Disclosures, including interest disclosures • Title (if group, company etc. identified in Title)
Role of perception • Attribution depends on what the reader notices, not merely what is disclosed. • An article with comprehensive “transparent” disclosures, but which places key facts about its provenance and development in the small print while letting secondary details capture reader attention, is poorly attributed.
Testing attribution • Does the attribution of an article actively bring to the reader’s attention the truth about its provenance and development? • Salience – are the most important facts isolated and presented to the reader? • Conspicuity – Are the most important features brought prominently to the reader’s attention at the outset of articles? • Clarity – are facts presented to readers in clear, unambiguous, non-euphemistic language? • Inclusiveness – are any key facts omitted?
Table 1. Understanding attribution
Advocacy marketing, content intended messages. Secondly, this literature’s the use of editorial teams and writers; and steerage, and attributional attribution is assigned primarily to academic company review. Collectively, these devices spin recruits.9 In rare cases, content is simply provide extensive opportunities for content Advocacy marketing (Table 2) is in my written by a company, then “authored” steerage. Of note, GPP3 requires that opinion the single greatest ethical problem without modification by a KOL. More authors “control” manuscript development in contemporary industry publications. generally, in my experience however, when and make “final” decisions, but the wording Advocacy marketing occurs in numerous marketing influences scholarly literature, is subtle: GPP3 does not require that authors retail sectors, when products are promoted content is developed with academic should have sole control or make all by members of the public or respected participation but subtly steered decisions.12 Authors do not; personas rather than by salespeople. This by the company to incorporate and in any case, most are the encourages consumers both to trust and to commercial perspectives, after Attribution of company’s trusted acad emic respect product messages – two key mark - which its attribution is subtly industry literature recruits or its employees. et ing objectives. In pharmaceutical mark - spun to exaggerate its academic commonly Attribution of industry eting, advocacy occurs when commercial credentials, while the company emphasises literature commonly emph- data and argument are presented to that is the true master is credited academic asises academic leadership. It customers – chiefly, practicing clinicians – with mere “support” or leadership. is common practice to place by respected academics rather than by the “sponsorship”. academics and their instit- company itself. Many academic “advocates” With respect to article content, the GPP3 utions conspicuously at the head of author are recruited by pharma for their status as guidelines illustrate many points at which it bylines, whereas industry employees are “key opinion leaders” also known as can be commercially guided. These include generally placed inconspicuously in the “KOLs”.5-8 Others are “rising stars”, with publication planning, which may propose middle or towards the rear of bylines, and whom companies cultivate longstanding themes, provisional titles, authors, journals are often fewer in number than academic relationships beneficial to the company and and messages;5,10-12 author selection, either recruits.9,14 There is rarely any prominent academic alike.8 directly by companies or indirectly by identification of the company, for instance In publications, advocacy involves two committees initiated by companies; in the title of the article or as a corporate co- steps. Firstly, companies shape the content inclusion of company co-authors on most author. Where it is identified – for instance of literature to deliver the company’s industry trials;13 company analysis of data; at the foot of abstracts – it is misleadingly
26 | March 2016 Medical Writing | Volume 25 Number 1 Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation – Matheson
Term Definition Advocacy marketing Presentation of marketing-related data or argument to potential customers through their peers and opinion leaders, not company representatives. Corporate authorship When a company considered as an entity plays an authorial role. Corporate ghost authorship When corporate authorship is not given an appropriately frank and prominent attribution. Disposable author Academic author recruited into a commercial project who could readily be exchanged for another without significant impact on the project or publication. Content spin Subtle steerage of content through planning, message formulation, research design, results analysis, author selection, manuscript development or review. Attribution spin Subtle spinning of attribution through authorship, author sequence, vague language, euphemism, omission, poor labeling and small print. Cultural corruption State in which the norms of conduct and ethics within culturally linked institutions and discourses are distorted by cultural change – typically involving money or power. Commercial-academic Blending and merger between commerce and academia, such that the distinction between what is assimilation commercial and what is academic becomes progressively less apparent and less important.
Table 2. Terminology used in this analysis credited with mere “funding” or “support.” ethical problem for academic recruits is, in company data; promoting compliance with Contributor listings generally do not my opinion, not that they are “guest research guidelines; enforcing trial distinguish company from academic co- authors” – most are not – but rather that registration; and improving interest authors and are presented in small print. they are positioned as leaders when their disclosures.1-4,15,16 Yet none of these Interest disclosures typically bury academic involvement is a contingent detail. If they or measures challenges the exaggeration of relationships with the company amid a mass their institutions had been unavailable, or if academic roles and understatement of of small print disclosures. Writers are usually the company’s choice had been different, commercial ones upon which advocacy denied co-authorship and acknowledged alternative institutions and academic marketing depends. Rather, the ICMJE only in small print. Textual descriptions of authors could and would have been selected. Recommendations assist these practices – the company’s role generally omit key facts, The actual academic who is recruited is not they exclude writers from byline authorship such as company instigation or private data decisively important. What is vital – as of research articles; set no requirements for ownership, and indeed GPP3’s recomm - much to marketing as science – is that corporate authorship; permit omission and endations for disclosure omit these facts. academics per se are recruited. The individ - euphemism in descriptions of industry’s The collective effect of these practices is to ual academics who happen to sign on are role, for instance in recommending terms position senior academic authors as leaders therefore what may be such as “funding”, “support” of publications planned, financed and termed disposable authors.9 Medical journal editors and “sponsor”; and provide drafted substantially by companies who (Table 2) Regardless of the have taken many no advice on what analyse and secretly own the data. Such scale of their contribution, valuable steps to uphold information should be attributional practices provide academic they are conditions of scientific and ethical brought more actively to endorsement, and as Hirsch has noted, may possibility for a company standards in journal readers’ attention.4 Conseq - increase the likelihood of publication in project that would proceed literature. Yet none of uently, articles planned, prestigious journals, whose editors and regardless of their particular these measures financed, and drafted by readers may prefer to see academics at the involvement. It is therefore challenges the companies and report ing head of bylines.14 unethical for such particip - exaggeration of academic their secretly held data ants to head the attribution roles and continue routinely to be Disposable authors and of this literature. understatement of published under supposed corporate ghosts commercial ones upon academic leadership. This picture of content steerage and Editorial guidelines which advocacy attributional spin leads to further new support advocacy marketing depends. Cultural corruption concepts in commercial publication ethics. Medical journal editors have and commercial Firstly, ghostwriting remains controversial taken many valuable steps to assimilation in industry publications, but in my opinion, uphold scientific and ethical standards in All the practices I have described – advocacy the greater ethical problem is corporate ghost journal literature. These include improved marketing, misattribution of commercial authorship (Table 2). This occurs when a documentation of individual contributions, literature, corporate ghost authorship and corporate entity plays an authorial role but through contributor listings and acknow - disposable authorship – require the is not assigned a commensurate attribution ledgements; enforcement of author participation of drug companies, marketing in the published article. Secondly, the chief accountability; securing author access to companies, publishers, journals and
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Recommendations
For any article financed by a company and reporting on its product, in which the company, its employees recruited academic authors. These and subtlety of change wrought or hirelings have participated at any stage, the first stakeholders all benefit according to their within science and medicine, and author should be the company itself. Alternatively, interests – indeed, the culture of contemp - editorial opinions differ over the company should be named at the beginning or orary industry publications could not whether industry’s presence is end of the title. endure were not the interests of all harmful or beneficial.19,20 Perhaps For all articles financed by industry, the Abstract stakeholders met. Thus, academics gain the most troubling trend is best and Introduction should state the article’s prominent authorial credit, and their careers characterised not so much as a commercial provenance and marketing functions. benefit from the research and publishing deflection, deception or corrupt ion Research articles should include a dedicated opportunities they find in industry of traditional academic discourse “Commercial Considerations” section in the partnership. Drug companies obtain pub - but rather a gradual merger between Methodology, explaining the commercial rationale lications and endorsements to promote their the domains of commerce and and how this influenced the study design. products. Marketers secure lucrative medical science, generating a hybrid There should be joint measures by journals, publications contracts with the corporat - research culture in which the societies, and academic institutions to ban physician ions; journals receive copy for their pages; distinction between what is advocacy from medicine. and publishers receive substantial reprint scientific and what is commercial is revenues. All of them benefit – and yet are by slow decrements becoming less able to claim that their conduct is fully apparent and less important. Such ICMJE-compliant, meticulously transparent commercial-academic assimilation is should not front this literature. I have argued and ethical. occurring on many levels: institutions and that the ICMJE Recommendations facilitate Lessig has defined “institutional corrupt- the geographical organisation of research; these practices, and that biomedical science ion” as a state in which “there is a systemic universities, research groups, research is threatened not merely by commercial and strategic influence which is legal… that personnel and academic appointments; corruption, but by creeping merger between undermines the institution’s effectiveness by clinical research; and publications, whose the worlds of science and commerce. diverting it from its purpose or weakening webs of small print disclosure function more To address these issues, the medical its ability to achieve its purpose.”17 Insofar to integrate than differentiate the contrib - editorial community must develop a more as medical research and publishing can be utions of commerce and academia. The sophisticated conceptualisation of attrib - considered as “institutions”, then they are practices described in this essay are ution. Editors must understand that while vulnerable to institutional corruption as pernicious not only in respect of advocacy transparency, disclosure and documentation Lessig has defined it, due to the systematic marketing but also because they too subvert are vital, they do not equate with good and strategic influence of pharmaceutical the boundary between what is commercial attribution if readers are not actively marketing. and what is not. Once commerce becomes presented with the most salient facts about I want here, however, to place the notion so blended into academia that its presence the material they are reading. Academic lead of “institutional corruption” within a more becomes a mere detail, routine in nature and authorship should never be allowed to generalised framing. The drug industry, giving little pause for thought, dominate attribution; and there biomedical science, medicine, marketing then marketing’s campaign for should be vigorous measures, and the publishing industry – Foucauldians access into the soul of medicine The problems of conducted in collab oration with would refer to the interconnected whole as is won. misattribution in academic institutions, to ban a “dispositif”5,18 – is composed of a mesh of commercial physician advocacy from institutions, practices, discourses, traditions Policy proposals literature could medicine. and cultures that are in a process of In this essay I have argued that be solved by The problems of misattrib - continual interaction and evolution. What attribution is a poorly developed taking corporate ution in commercial literature Lessig would term “institutional corruption” concept in medical editorial authorship could be solved by taking occurs when commercial drives within this thought; that the attribution of seriously. corporate authorship seriously. setting deflect the scientific, clinical and industry literature frequently For any article financed by a publishing domains from their traditional exaggerates its academic and downplays its company and reporting on its product, and goals. Because commercial forces reach commercial credentials, in the service of in which the company has participated in across many institutions and discourses, the advocacy marketing; that companies are research or manuscript development, I term “cultural corruption” is to be preferred frequently corporate authors, such that recommend that the first author should be the to “institutional corruption”, although the corporate ghost authorship is an important company itself – for example, Merck, Inc. latter term remains valid within individual problem; and that academics who make Other authors could remain unchanged, institutions and discourses. Yet the term honest contributions are nonetheless although in my opinion writers should be “corruption” does not capture the full range contingent, “disposable authors” who co-authors. An alternative would be to begin
28 | March 2016 Medical Writing | Volume 25 Number 1 Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation – Matheson
or end the title of the article with “A Merck, bodies are the ultimate target of the vagaries and small print in reporting Inc. Trial”. In addition, for all articles marketing enterprise. Measures such as industry roles, and to respect and vigorously financed by industry, including review these would not only prevent misattribution defend the distinction between commercial articles and consensus statements, the and reduce advocacy but would bolster the and noncommercial science. In my opinion abstract and the introduction should state: distinction between commercial and the publications trade needs new guidelines, “This article has been planned and financed noncommercial science and combat cultural a new trade association, and new leadership by Company X with assistance from YZ blending. To support this goal and assist to realise these goals. Medical Communications, in connection research on industry practices, the US with the marketing of Drug D, a Company National Library of Medicine should Conflicts of Interest and X product.” There should also be a introduce an obligatory new publication Disclaimers dedicated “Commercial Considerations” category, “Commercial”, for all industry- Between 1994 and 2012 the majority of my section within the Methodology section, financed literature. income came from consultancy and writing explaining the commercial rationale and services provided to pharmaceutical how this influenced the review themes or Conclusion corporations, either directly or via study design. For instance: I end with an appeal to my friends in the marketing agencies. In 2015 I acted as a paid “The study proprietors, XY Pharma, pharmaceutical and publications trades. expert witness on behalf of the plaintiffs in chose to measure 24-hour blood pressure There is much to celebrate in mercantile a US federal legal action against a control rather than absolute blood science, as pharma’s own traditions of pharmaceutical corporation. pressure reduction in this study in part scientific research and discovery I received no support, remuneration or because the investigational product they demonstrate. Likewise, collaboration benefits of any kind for researching and manufacture, votasartan, has a long between commerce and science can be writing this article. elimination half-life, and is therefore beneficial, and whether welcome or not, I consider myself a supporter of bona fide likely to perform favorably according to increasing commercial-academic interaction scientific research including for-profit 24-hour assessment. The proprietors is the reality we must live with. The industry research but an opponent of chose the comparator drug, plodipine, in challenge then is to maintain scientific rigor, marketing practices in the setting of part because votasartan is competing for frankness, freedom from bias, and scientific research and publication. its market share, and in part because intellectual independence in a world of while plodipine yields greater absolute growing commercial partnership. Much of blood pressure reductions than today’s commercially financed medical votasartan, it has a shorter elimination publications culture is an exemplar for how half-life, offering potential advantages for not to achieve this: its output is vulnerable votasartan with respect to the selected to bias in framing and content, may assessment criteria. The proprietors incorporate subtle commercial positioning References conducted the study at 35 centres rather into scientific text, and may report or discuss 1. Huth EJ, Case K. The URM: twenty- than a small number of centres, because research that is designed to sell rather than five years old. Science Editor 2004; 27: while statistically less robust, this enabled discover; whose patient-level data are secret; 17-21. them to familiarise more physicians with and their attribution is commonly spun the 2. Rennie D, Yank V, Emanuel L. When the use of votasartan, which may lead to better to impress readers. Many trade writers authorship fails. A proposal to make higher sales.” are former scientists, who understand the contributors accountable. JAMA 1997; importance of absolute truthfulness and 278: 579-585. These or similar measures should have been frankness in the way science is done, and 3. Rennie D. Integrity in scientific enforced by journals decades ago, but that who, I believe, know that whatever the publishing. Health Serv Res 2010; 45: would have been incommodious to ICMJE might allow, the published output of 885-896. advocacy marketing, to academic authors, the pharmaceutical, marketing and 4. International Committee of Medical to the vanities and anxieties of professional publications trade too often falls short of the Journal Editors (ICMJE) medical culture, and to publishers eager to standards science should attain. Not only do Recommendations for the Conduct, fill journals with literature and coffers with science, medicine and patients deserve Reporting, Editing, and Publication of reprint sales. The only beneficiaries of better, but the trade deserves better – to Scholarly Work in Medical Journals truthful attribution and a true description of have the frankness to call itself a trade, to be (ICMJE Recommendations). Available: commercial considerations would be open with readers about the commercial http://www.icmje.org/ scientific integrity, the scientific record, objectives of publications, to abhor recommendations/. Accessed journal readers, and their patients, whose euphemism, omission, understatement, November 30, 2015.
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5. Matheson A. Corporate science and the 15. Davidoff, F, C.D. DeAngelis, J.M. husbandry of scientific and medical Drazen, M.G. Nicholls, J. Hoey et al. knowledge by the pharmaceutical 2001. Sponsorship, authorship, and industry. BioSocieties 2008; 3: 355– accountability. New England Journal of 382. Medicine. 345:825-826. 6. Sismondo S. Key opinion leaders and 16. DeAngelis CD, Drazen JM, Frizelle FA, the corruption of medical knowledge: Haug C, Hoey J, Horton R, et al. what the Sunshine Act will and won’t Clinical trial registration: a statement cast light on. J Law Med Ethics. from the International Committee of 2013;41:635-43. Medical Journal Editors. JAMA. 2004 7. Moynihan R. Key opinion leaders: Sep 15;292(11):1363-4 independent experts or drug 17. Lessig L. “Institutional corruption” representatives in disguise? BMJ. defined. J Law Med Ethics 2013; 41: 2008;336:1402-3. 2-4. 8. White Paper: Key Opinion Leader 18. Foucault, M. (1980). The confession Identification and Selection. A Pharma of the flesh. In M. Foucault (C. Gordon, Andrew Walker Matters Report. Thomson Reuters, Ed.), Power/knowledge: Selected Clinical Information Science Director January 2009. Available: interviews and other writings, 194–228. AstraZeneca http://www.slideshare.net/driceman/ Brighton: Harvester Press.P 195. Alderley Park, UK kol-management?related=1 Accessed 19. Horton R. The Dawn of McScience. November 10 2015. New York Review of Books. March 11 9. Matheson A. The disposable author: 2004. Correspondence to: how pharmaceutical marketing is 20. Drazen JM. Revisiting the commercial- Andrew Walker embraced within medicine’s scholarly academic interface. N Engl J Med Clinical Information Science Director literature. Hastings Center Report 2014;372;19:1853-4. AstraZeneca 2016; 10.1002/hast.576. Alderley Park 10. Wittek MR, Williams MJ, Carlson AM. UK Evidence development and publication [email protected] planning: strategic process. Curr Med Res Opin. 2009;25:2723-7. 11. Sismondo S. Ghost management: how Abstract much of the medical literature is shaped This interview provides solutions to behind the scenes by the some of the common pitfalls that face pharmaceutical industry? PLoS medical writers when working with large Medicine 2007; 4: e286. teams. Practical tips are provided on key 12. Battisti WP, Wager E, Baltzer L, Bridges topics including manuscript planning, D, Cairns A, Carswell CI, et al. Good agreeing on key messages and the use of Publication Practice for figures, tables and other contents, Communicating Company-Sponsored deciding on the criteria for authorship, Medical Research: GPP3. Ann Intern Author information and dealing with contributors who fall Med. 2015;163:461-4. Alastair Matheson, PhD, worked as an short of their commitments. 13. Hoekman J, Frenken K, de Zeeuw D, independent consultant and writer Heerspink HL. The geographical specialising in product analysis, public - distribution of leadership in globalized ations planning, and manuscript develop - Professor Ruth Roberts is founder and clinical trials. PLoS One 2012; 7: ment in the pharmaceutical, marketing, director of ApconiX, a pre-clinical consult - e45984. and publications industries from 1994- ancy and ion-channel expertise company 14. Hirsch LJ. Conflicts of interest, 2012. He has worked with over 20 based in the UK. In the last 20 years, she has authorship, and disclosures in industry- medical communications agencies and published over 130 peer-reviewed research related scientific publications: the tort most of the major pharmaceutical articles and reviews as well as numerous bar and editorial oversight of medical corporations. He retains friendships and scientific posters, several book chapters and journals. Mayo Clin Proc. 2009;84: contacts in these trade sectors. two books. In addition, she has been chief 811-21. editor for several authoritative text books.
30 | March 2016 Medical Writing | Volume 25 Number 1 Perspective from a leading scientific author: An interview with Professor Ruth Roberts on authors and authoring
As expected, most of these publications been put together on aeroplanes somewhere viewpoint on key messages and the rank of have had multiple authors and input from over the Atlantic whilst everyone else is importance. For example, an experimental large multi-disciplinary teams. watching a film. pathologist will want to position the path - The author’s questions (Q) and Prof - If you’re working on a manuscript with a ology data centrally, whereas a toxicologist essor Roberts’s answers (A) provide tips for key opinion leader or a subject matter might want the general toxicology data to driving collaborative manuscript production expert, remember that they are usually busy take centre stage. including resolving authorship issues and people. It’s essential to plan well ahead in It’s essential that the key messages and other challenges that face anyone involved order to get their input. their priorities are discussed as early as in such work. possible and agreed at the outline stage, and Q: What are the biggest challenges that certainly before proceeding with the first Q: You have an impressive publication you face when working with co-authors? draft. record with one article produced every A: One of the perennial challenges is getting couple of months. How do you find the agreement on the key messages of the work. Q: When you’re leading the development time and inspiration? The analysis itself can be problematic but of a manuscript, how do you decide who A: I don’t consider a research project or framing those messages in a way that best will be an author on the paper? Are they other piece of work to be finished unless it meets the needs of the primary audience can all equal or do some contribute more is published. In addition to analysing the generate lots of discussions. Consequently, than others? We’re all familiar with the data, starting work on the draft manuscript as an author, that’s one of the things that I order of authors but what do they mean is something I really look forward to. I have prioritise with the team at a very early stage. to you? to be very efficient with my time and that That said, there can also often be dis - A: The first and somewhat easiest criterion includes the need to set aside the time to agreement around identifying the primary I use is the contribution of data. Anyone work on papers. Because I’m so busy I look audience. From my experience, a good paper who has contributed data during the project at my schedule for the coming weeks and will often span several disciplines which will be included as an author. That’s the identify time periods where I can concen - provide different perspectives and context. easiest one to deal with. After that it gets trate on drafts or outlines or arrange Working with such a diverse team brings more complicated. People who have taken meetings with collaborators and co-authors. about its own complications as each an active part in shaping the paper or who Many of my outlines and initial drafts have member usually has his or her own specific may have taken the lead in writing specific,
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technical or expert sections are also included Q: Having agreed who the authors are, responsibilities, a firm hand is needed to as a rule. Occasionally I may get a request to how do you agree as a team on contents drive the project forward and to keep to the include someone’s boss or co-worker and how do you resolve any issues? planned schedules. However, when dealing because they reviewed an early draft. The A: I usually get the team to start with a blank with co-authors, I always ensure my political situation can be a minefield but I sheet of paper and build a story board from decisions leave me with a way forward. After try to be as fair and consistent as possible. scratch. After the initial brain-storming all, collaboration or networking is the However, having said that, I find that on session, we usually end up with bits of paper lifeblood of good science. In practical terms, many occasions it’s reasonable to acknow - pinned all over the wall and spread over the I’ll always follow up on difficult decisions ledge people who have been kind enough to floor. We then go through the story and with a phone call and then follow up with an review the draft and provide editorial determine how the proposed data or key email that confirms, in writing, what has comments. Unfortunately, they don’t always message described on each piece of paper specifically been agreed. see it that way and feel that such a minor contributes to the manuscript. Anything If people lose interest or don’t deliver on contribution warrants an authorship. superfluous to the main story gets put in their commitments, I will escalate the issue ‘back up’ for later consideration! (usually by email so providing a written Q: Indeed, sometimes inter-depart - One of the most challenging parts of this record) and state that if there has been no mental politics can be very problematic. approach is to try and keep the story as clear response by a specific date, it’s assumed that You must have struggled with such and simple as possible. Quite often there is they no longer want to be part of the paper. authorship issues and it’d be interesting a desire from a team member to include a This is the ultimate sanction but no one to hear your tips for resolution. For piece of data solely because the work has really wants to go there. example, have you had to deal with a been done, as opposed to it contributing to colleague who received an acknowledge- the story. In one recent extreme case, a Q: Is there one particular paper that ment rather than an authorship and potential author tried to argue for inclusion stands out as being difficult to get into wasn’t happy with that decision? of data solely on the basis that he had spent print? A: I haven’t struggled personally because I hours generating statistics and beautiful A: There have been a few. A difficult one try to be as fair and consistent as possible graphics. It took a while to convince him recently came from a consortium of some 40 but others have struggled with my decision! that the data, whilst wonderfully presented, scientists from academia, industry, and Usually, the problem lies around the weren’t relevant to the paper that we were regulators that I was leading. Each of the 40 perception of the level of contribution by an trying to construct. contributed to the work of the consortium individual; it’s a difficult area. I consider that It’s easy to get lost in the details of the to some extent but not all contributed to the reviewing the document and offering data so start with a ‘rough sketch’ story paper so we had to tease apart authorship, editorial comment qualifies for an acknow - board – what are the key points or messages acknowledgement, and ‘no part played’. ledgement. On the other hand, engaging and how does one assemble them into a Layered on top of this was the approval to with the data and offering reasoned, logical order? Use a ‘straw man’ to get the publish processes from 40 different inst it - substantial changes to their interpretation is creativity going and be controversial to utions. I nearly gave up on this one but in the worthy of inclusion as an author. engage your team in discussion. end dogged determination paid off! As with With experience, it’s often apparent from A good, functional storyboard may be any project, early discussion and agreement the outset where and with whom these nothing more than a sketch of the results of the story, the authorship, and good issues may arise. In order to prevent section so resist the urge to start generating project management paved the way for a derailing the process at a later stage, I elaborate diagrams or detailed tables until successful, if somewhat drawn out outcome. distribute the International Committee of you have agreed the message. Medical Journal Editors (ICMJE) guide - Be prepared to ditch data sets that don’t lines to the authoring team whilst we are add anything to the story, or even better, agreeing on the outline for the manuscript. consider how they may contribute to the On one paper earlier this year, several next manuscript! Author information people who received acknowledgements for Andrew Walker, PhD began his medical editorial comments on a recent manuscript Q: As a lead author, how do you deal with writing career in 1996 and has worked as protested that they should be authors; I collaborators who don’t fulfill their a freelancer, as an agency writer and also responded that they were welcome to set obligations? in-house for AstraZeneca. In this time he out how their comments had altered or A: Firmly! Like any project, developing a has worked extensively on regulatory contributed significantly to the scientific manuscript quickly and efficiently requires documents, publications and training conclusions of the paper. In the end none of good leadership skills. Once the storyline is materials. them came back to challenge my decision! agreed and the authors are aware of their
32 | March 2016 Medical Writing | Volume 25 Number 1 Authorship of clinical trial documents
Raquel Billiones Introduction Clinical Study Protocol (CSP) Clinipace Worldwide Clinical study protocols (CSPs), clinical The contents of a CSP are based on ICH E6 Zurich, Switzerland study reports (CSRs), investigator’s broch- (Guidelines for Good Clinical Practice, ures (IBs) and informed consent forms 1996)1 and the ICH E6 integrated adden - (ICFs) are among the most common dum (2015)2. The protocol is frequently Correspondence to: documents that regulatory medical writers written by a regulatory medical writer who [email protected] author as professionals. Unlike publications receives input from other functional groups. where authorship has been under scrutiny Contributors to the document will include, in recent years, authorship of CSPs, CSRs, but are not limited to, a biostatistician and a Abstract and other clinical trial documents has not medical expert. In some cases, investigators Authorship of publications has been the really been a topic of discussion. This is or clinical research scientists also draft a subject of much public debate; however, probably because these documents have CSP with or without the support of a authorship of clinical trial documents traditionally been hidden behind the shroud medical writer. such as clinical study protocols, clinical of confidentiality. The ICH E6 guideline does not provide study reports, investigator’s brochures However, with increasing requirements guidance with respect to authorship and informed consent forms has not for transparency having reached the realms attribution of the CSP. However, it does really been given much attention. This of regulatory documents, it is about time indicate the individuals and institutions who article looks at the common practices of that authorship attribution of these should be signatories of the final protocol, authorship attribution and signing off on documents should be considered. As we namely, the ‘investigator/institution and the these documents and examines what the move towards posting some of these docu - sponsor’. In signing off the protocol (‘or an ICH guidelines, on which their contents ments in the public domain, it is also alternative contract’), these individuals and are based, say about these issues. The important to see the implications of institutions thereby declare their commit - implications of the EMA Policy 0070 on disclosure on the authors and signatories of ment to follow the protocol and abide to the clinical trial disclosure are discussed. these documents. principles of Good Clinical Practice (GCP). The CSP eventually ends up as part of appendix 16.1.1 of the CSR, which is
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 33 Billiones – Authorship of clinicial trial documents
expected to be posted in The CSR and Assuming that these have written for clients, an institutional the public domain under CSP are the two most two terms of authorship author (company name) is provided on the EMA Policy 0070 important clinical trial are used interchang eably, in the title page and the synopsis. A Publication of Clinical theory, the medical responsible medical officer on the Data for Medicinal Prod - documents impacted by writer(s) who drafted the sponsor side will sign off on the report. ucts for Human Use3,4. disclosure through the text sections of the CSR Appendix 16.1.4 may or may not list Only the names of EMA Policy 0070. ICH E6 would qualify as author(s) individuals or institutions responsible for investigators may be does not provide any of the report. The bio - CSR development. disclosed. If other names guidance on authorship statistician(s) who provide 3. A CSR is a shared endeavour and resp - appear in the protocol, of CSPs. ICH E3 provides the statistical outputs onsibility is across the functional groups. these may need to be would qualify as well. I have had clients who insisted on redacted or the concerned somewhat unclear Other roles that would be naming the medical writer, the bio - individuals may need to recommendations for considered for authorship statistician and the medical officer as sign a waiver to disclose authorship of CSRs. or contributorship are the authors of the document. Furthermore, their personal data. Moving The CORE Reference site staff (investigators and they usually expected these authors to be for ward, it might be may provide much subinvestigators) as well as signatories in appendix 16.1.5. advisable for the signatories needed clarity. the sponsor and the It is important to clarify that the authors to sign off on an alternative contract research organis - and the signatories of a CSR are not contract that is not part of the ation (CRO) staff (if used). necessarily the same people, as in scenarios main document, an option that is provided In practice, attribution of authorship is #1 and #2. For the signature page in for in ICH E6. usually dependent on company policy. appendix 16.1.5, the minimum requirement Below are a few scenarios that I have is for the sponsor’s responsible medical Clinical Study Report (CSR) encountered over the years. officer to sign off on the document. In CSRs are more often than not written by 1. Authorship of CSRs is, by default, European studies, the signature of the regulatory medical writers. The CSR has a attributed to sponsor personnel. If CSR coordinating investigator is also required.7 dedicated ICH guideline (ICH E3 Structure writing is outsourced, the medical Scenario #3 is especially controversial as and Content of Clinical Study Reports writing company, consultant or CRO will some medical writers do not feel com - 19975 and Q and A update 20126), thus be listed in appendix 16.1.4 as being fortable in signing off on such an important belying its importance. It is also the responsible for writing the CSR. How - document. With the requirement to disclose centrepiece of the EMA Policy 00703 and its ever, the title page of the report would CSRs in the public domain, the reluctance implementation. only list the name(s) of the sponsor’s to sign has increased. It should be noted Authorship is mentioned in two sections responsible person(s) and one, some or that, based on the EMA policy 00703,4 on of ICH E3. all of these people will be the CSR CSR disclosure, sections 16.1.4 and 16.1.5 In Section 6 Investigators and Study signatories. will not be posted publicly. Hence, based on Administrative Structure, the guideline 2. There is no authorship attribution to any the current disclosure policy, attribution of recommends that a list of people ‘whose individual. In many CSRs I authorship to individuals in these participation materially affected the conduct sections does not amount to of the study should also be ...... disclosing their personal data. provided in appendix 16.1.4.’ However, even this argument ...... This listing should include ‘…the STUDY TITLE ..... cannot allay concerns of author(s) of the report, including ...... possible legal implications. the responsible biostatistician(s).’ STUDY AUTHOR(S) If we argue that the terms Authorship is also touched report author(s) and study upon in appendix 16.1.5 I have read this report and confirm that to the best of my knowledge authors(s) are not synony - Signatures. In the sample signature it accurately describes the conduct and results of the study. mous, we might have to go form provided in Annex II of ICH ...... down the road of defining ...... E3, the term study author(s) is used INVESTIGATOR metrics for an individual’s (Figure 1) but the authors are not ...... level of involvement and necessarily the signatories of the SIGNATURE ...... contribution to a clinical CSR. The distinction between report OR SPONSOR’S RESPONSIBLE study. This, however, would author and study author (if any) is not MEDICAL OFFICER be a discussion that is clearly specified in ICH E3. Figure 1 beyond the scope of this article.
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In my search for further clarification References on authorship of and signing off on 1. ICH E6 (R1) Guideline 1996. a CSR, I reached out to Sam Guideline for Good Clinical Hamilton (personal commun - Practice. ic ation), chair of the 2. ICH E6 (R2) Budapest Working Group Guideline 2015. (BWG). This group is Integrated Addendum to developing the CORE ICH E6 (R1): Guideline (Clarity and Open - for Good Clinical ness in Reporting: E3 Practice. based) Reference as 3. EMA Policy 0070 02 an open access user October 2104. Policy on manual for CSR authors, with Publication of Clinical planned release in May 2016. Data for Medicinal CORE Reference will recommend Products for Human Use. inclusion of a list of roles and responsibilities 4. EMA 07 September 2015. in Section 6 detailing invest igators (prin - Key aspects related to the cipal or coord in ating), data monitoring and submission of clinical reports for the evaluation committees, and labor at ories. purpose of publication in accordance The BWG also recommends specifying with EMA Policy 0070. study responsibil it ies clearly and study 5. ICH E3 Guideline 1997. Structure and activities of the institutions in volved, Content of Clinical Study Reports. including report authoring and biostat istics 6. ICH E3 Guideline 2012. Structure and with details provided in CSR appendix Content of Clinical Study Reports 16.1.4. Questions & Answers (R1). What about the reference to study auth- 7. EMA-CPMP 2001. Note for Guidance orship in appendix 16.1.5 (Figure 1)? on Coordinating Investigator Signature CORE Reference will advocate the of Clinical Study Reports. consistent use of report authorship and CSR authorship throughout the document. Disclaimer CORE Reference will not suggest the The views and opinions in this article are medical writer as an appropriate co- solely those of the author and do not reflect signatory for a CSR, because it is not those of Clinipace Worldwide. mandated by existing regulatory guidelines. In reality, CSR signatories over and above those required according to ICH (or the relevant country or regional guidelines) remain a matter for individual sponsor Summary consideration or policy. In summary, regulatory medical writers continue to create key regulatory docu - Investigator’s Brochure (IB) ments for clinical trials. The CSR and CSP and Informed Consent Form are the two most important clinical trial Author Information (ICF) documents impacted by disclosure through Raquel is a Senior Director for ICH E6 also covers the contents of the IB the EMA Policy 0070. ICH E6 does not Regulatory and Medical Writing at and the ICF. As in the case of the CSP, no provide any guidance on authorship of the Clinipace Worldwide. She has more than authorship attribution for these documents CSP, IB and ICF. ICH E3 provides 25 years’ experience as a life scientist and is specified in the guideline. But, unlike the somewhat unclear recommendations for regulatory medical writer and is an CSR and CSP, these documents will not be authorship of CSRs; CORE Reference may advocate of transparency and disclosure posted publicly but will remain filed in the provide the much needed clarity. If handled in clinical trials. She is currently serving Trial Master File. Hence, the authorship appropriately, authorship attribution of and as Honorary Secretary on the EMWA attribution of these documents is less likely signing off on CSRs need not be impacted Executive Committee. to become an important issue in the future. by public disclosure.
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 35 Project management in medical publication writing: A less explored avenue in pharmaceutical companies and clinical research organisations
Prashant Auti, Rishabh Pandey, Correspondence to: Vatsal Shah Prashant Auti, SIRO Clinpharm Private Limited, SIRO Clinpharm Pvt Ltd, Thane (W), India Kalpataru Prime, 1st floor, Unit Nos. 3 & 4, Plot no. D-3, Road no. 16, Wagle Industrial Estate, Thane (W) - 400 604, Maharashtra, India. Tel: +91 22 6108 8145 [email protected] [email protected]
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script publication has increased. The rapidly with the advent of highly soph- Abstract publication of drug research in reputed isticated publication planning tools such Drug development forms the core of the journals and at congresses increases the as PubSTRATTM (from Sylogent) and pharmaceutical industry. Medical writing impact of the results in the scientific DataVisionTM (from Envision pharma is a key function in pharmaceutical community and is a major channel of group). Publication planning tools have companies and clinical research organ - communication of scientific advances to a revol ution ised the publication industry by isations that works on scientific pub - wide range of healthcare providers.1,2 A accelerating the planning and execution of lications and regulatory dossiers. staggering number of scientific publications publication projects.1,2,3,6 Regulatory writing steers the drafting are published each year, with scientific output All these particulars illustrate that and submission of regulatory dossiers doubling every nine years.6 Many well- medical PW is emerging as one of the most and safety reports to health authorities; known universities across the globe, such as important departments in pharmaceutical medical publication writing on the other the John Hopkins University,7 the University companies, publication houses, and clinical hand deals with scientific publications of Chicago Graham School,8 and the research organisations (CROs). Due to the such as manuscripts, abstracts, present- Massachusetts Institute of Technology9 to huge expenditure of time and money in ations, and posters. Project management name a few, have already launched courses addition to regular expenses such as research is essential for the expedited execution and curriculum on medical publication/ and manufacturing, many pharmaceutical and seamless delivery of publication science writing and editing. Many universit - companies outsource PW work to CROs or writing projects with a quick turnaround ies even have a department dedicat ed to pharma knowledge processing and out - time. End-to-end project management of scientific publishing that keeps track of all sourcing (KPO) companies. Irrespective of publication writing projects on the lines publications and supports their drafting and the type of company, there is always a of five-stage process of the Project editing. Nowadays various international requirement to have set processes in place Management Body of Knowledge research institutes and govern ment agencies for the seamless execution of a project, (PMBOK) is discussed in this article. fund academic research with potential, with which brings the principles of project a component of the grant allocated for management into the picture. Challenges publication support.1,2 faced in the execution of PW projects are Introduction McGuigan and Russell10 noted that the unique and different than those faced in Medical writing is a diverse field originated scientific, technical, and medical segment of conventional regulatory medical writing. In from the need of pharmaceutical companies the academic journal publishing industry this article, we discuss project management to have a support function that works generates more than US$19 billion revenue in the PW department of a pharmaceutical exclusively on regulatory submissions and globally. Scientific publication has increased company or a CRO/KPO. commercial scientific communications.1 This function is responsible for the analysis, interpretation, and dissemination of scientific information.2 Regulatory writing steers the drafting and submission of regulatory dossiers • Principal authors Final approvers of and safety reports for health authorities; • Publication writers publication publication writing (PW) on the other hand • Project managers document deals with scientific publications, such as • Outsourced work to • Product team lead agency (CRO, KPO) • Clinical team lead manuscripts, abstracts, presentations, and • Statistics lead posters and falls under commercial writing.3 • Medical affairs lead PW is regulated by many publication-specific • Regulatory affairs lead guiding principles, such as good publication • Legal practice (GPP), recommendations of the • Patents international council of medical journal editors (ICMJE), con sol idated standards on reporting trials (CONSORT), the committee on pub li cation ethics (COPE) guidelines, and many others.1,3,4,5 With new stringent trial disclosure policies and an industry-wide obligation to Figure 1: Publication writing team structure Abbreviations: PW, Publication writing; CRO, submit trial results with medical importance Clinical research organisation; KPO, Knowledge processing and outsourcing for publication, the importance of manu- Note: PW team 1, 2, 3 represents PW teams working on various deliverables/projects.
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Figure 2: Implementation of project management based on PMBOK framework
Project Management in evaluations such as the needs assessment, with the client so that the expectations of Medical Publication Writing in and internal and external gap analyses. The both parties are aligned. For example, if the line with the PMBOK publication planning team plans public - CRO is requested to use the client’s Framework ations at every stage of drug development standard operating procedures (SOPs), Before discussing the actual process of and also based on the medical queries they they should be analysed to see if they will project management in PW, let us first receive at the medical information affect the time management aspects of the understand the structure and function of a management department.12,13 project. After the scope is defined and PW team in a pharmaceutical company or Project management in medical PW understood, internal research and CRO. A PW team comprises trained begins with the definition of the objectives discussion are conducted and a solution is professionals who have higher degrees in the and scope of the project. While pharma - devised. Internal team meetings are life science domain, including, but not ceutical companies have a publication arranged where the project manager and limited to, pharmacy, medicine, and clinical plan12 ready as part of a drug’s develop - medical writers discuss how to proceed research. The schematic depiction of the ment, project management of a PW project with the project. The strategies and working of a PW team is shown in Figure 1. in a CRO varies in the processes followed. processes to be followed for the timely The structure of a PW team may however In the case of CROs, the project is delivery of the project are defined, i.e. the vary depending on the functionality and size understood by communicating with the project is set up in a publication planning of the organisation .1,2,3 client (usually a pharmaceutical company tool where timelines and stakeholders for We propose a process of managing a PW or other service provider agency) and the each draft stage (initial draft, first draft, project in line with the five process groups drafting of a statement of work or a project second draft, and final draft) of the recognised in the Project Management Body charter. This is often achieved by deliverable (manu script/poster/abstract) of Knowledge (PMBOK) published by the conducting a kick-off meeting following a are defined.16 After the requirement Project Management Institute (PMI).11 formalised handover from business gathering, internal research and preparatory Among the many different deliverables in development to operations. The very first activities are carried out to determine the PW projects, most frequently encountered step to initiate the project is requirement deadline for each milestone. This includes are abstracts, posters, and manuscripts. gathering, where open-ended questions are the sharing of a content outline and getting Development of any medical publication asked to determine the project its approval from the client. Cost estimates document can be divided into five process specifications. For example, to develop a for publication planning in pharmaceutical groups: Initiation, Planning, Execution, manuscript, the following particulars can companies are prepared by the publication Monitoring and Control, and Closing clarify project specifications: author docu- steering committee and the finance (Figure 2).11 mentation (debarment, legal agreements department. In CROs, they are usually with external authors, authorship invitat - prepared during the business development Initiation ion), availability of data sources (reports, phase while negotiating with the client. Publication planning is a key aspect in the existing publications, study protocol, Estimated project hours and billable hours project management of PW. A publication statistical plan, or any other data source), per resource are taken into consideration to plan is developed by the publication steering the need for a comprehensive literature develop a cost estimate.11,12,13 committee and scientific publication team, search (important for reviews and meta- with the involvement of the publication lead analyses), quality control (data and editorial Planning and writers. The publication plan is dev - checks), and the number of review The planning stage begins once all project eloped in line with the drug development cycles.14,15 In the case of a CRO project, specifications are defined and a unique and product life-cycle by considering the scope should be discussed in great detail solution has been proposed. The first step is
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Pharma Brand Study Deliverable Write Subject Quality Start End Actual company Name ID matter reviewer date date project (Generic expert hours name) reviewer A X 1A Manuscript P CD DE 1-Jun-15 12-Aug-15 105 B Y 1B Congress poster Q GH HI 7-Jun-15 28-Jun-15 64 C Z 1C Scientific R LM MN 2-Jun-15 11-Jun-15 18 abstract Table 1: An example of a project tracker sheet
Tasks Technical Project Publication Review Authors Approvers Graphic Assistant Manager Writer Team Designer Requirement gathering and project set up R R, A C, I O C O O Kick-off and author documentation R R, A R, I O R, C, I O O Drafting and comment addressing O A R O C O O Review of the first draft O A I R R O O Design work; creating tables, O A R, C I C, I O R figures, layout, etc Review of the final draft O A I R R O O Final approval O A R O I R O Submission R A A O I I O
Adapted from: Dubois B. Fostering collaboration. The Write Stuff. 2011;20(4):219-21. Abbreviations: R, Responsible; A, Accountable; C, Consulted; I, Informed; O, Omitted from the loop. Note: the lead statistician is generally listed as an author; this matrix may change as per organisation structure and its requirements
Table 2: An example of a responsibility assignment matrix for writing a manuscript the assignment of project roles, which can online time management tools and a cross-functional/inter-departmental be achieved based on the skills documented common project tracker sheet.11,17 An business/project processes. An example of in the work profile of the writer and the example of a project tracker sheet is responsibility assignment matrix in a PW writer’s position in the organisation. A provided in Table 1. project for writing a manuscript is given writer’s work profile should be well cate - The availability of full-time employees below (Table 2).19 gorised with regard to their competencies, should be assessed quarterly as to whether Once the project roles have been prior experience, and their therapeutic area there is a need to allocate work to free - assigned, a work breakdown structure20 is expertise. Tasks such as complex manu - lancers, other agencies, or vendors.17 Overall created where an activity is divided into scripts, manuscripts, or posters with limited availability is calculated based on the smaller tasks and these tasks are assigned to data sources, review articles, and primary number of project and non-project hours. team members. An example of a work break - manuscripts can be handed over to a senior Non-project hours include employee leave down structure for writing a manuscript is publication writer who has ability to and activities such as skillset training, self- given in Figure 3 overleaf. interpret statistical data whereas the task of learning, corporate activities, SOP training, drafting an encore abstract or poster can be and the maintenance of the staff training Execution given to a junior publication writer.17 In the folders. While assigning project roles, the The execution phase in medical writing case of CROs where there are no dedicated project manager should always pay heed to includes working in accordance with SOPs project managers, the publication lead might the requirement of a back-up writer as part to complete a particular task. For PW, it work as a writer-cum-project-manager and of the risk mitigation strategy. A back-up basically involves the drafting of the docu - manage internal and external communic - writer can do “fire-fighting” in cases where ment, review cycles, performing quality ations. He/she also has to ascertain if the the primary writer is unavailable due to ill- checks, and addressing comments provided contribution of assistant teams, such as health or other emergent work. Meticulous by internal and external stakeholders. publication technical support (handling the resource planning is important to the Sometimes project managers also have to publication tracking tool and other tech - successful implementation of the project, deal with external agencies, giving rise to nicalities) or the graphic design team, is since the definition of the project roles and vendor management. In the case of CROs, needed, and if yes, to what extent. The the formation of the project team are based vendors could include translation agencies, availability of resources with the required on this. A responsibility assignment matrix18 printing and publishing support vendors, or skills at a given time can be tracked using is one such tool to define project roles in freelance service providers.
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Writing a manuscript
Post-submission Preparatory activities Draft phase Submission activities
Collection or Shell draft (key requirement Pre-submission Address pointers of gathering document quality check Journal comments and data sources manuscript)
Author’s First draft (content Approvals from all documentation, development + stakeholders (authors, Galley proof medico-legal, clinical debarment checks formatting) team, IPR, etc)
Final draft Journal submission Journals selection (preparing (recreating figures, and literature search submission review, and edits) package)
Timeline setup and resource allocation in publication planning tool
Figure 3: Work breakdown structure for drafting a manuscript. Abbreviations: IPR, Intellectual property rights
Offshore operations management is first draft of the manuscript is written with review by an internal subject matter expert important for CROs working in different input from researchers and authors. Once (SME) and an editor. SME review involves a geographical locations all over the globe. the first draft is written, the scientific diligent check of the scientific content, the Offshore operations are carried out through content of the entire manuscript is reviewed correct interpretation of the data, important a global hybrid delivery model considering by the core publication planning team and discussion points, tone of the overall mess age geographical, cultural, and chronological comments are provided in case of in con - (language should not sound prom otional), variations. The project manager drives sistencies, which are then addressed by the and the proper citation of references. In the execution against the plan and has to publication writers. Once the first draft is case of CROs, points of contact (POCs) communicate regularly and openly with the approved, the writers prepare the second from the sponsor (i.e. the client) will review sponsor.14,17,21 draft in accordance with the journal the content from their perspective. Editorial We shall now review the important steps guidelines. The second draft is generally review is done by the medical editors to in the drafting of a manuscript. Initially, a considered to be the final draft; however check grammar and language. The writer- shell draft is written that includes all additional drafts can be made depending on cum-project manager acts as a bridge during important subject matter points in the form the number of review cycles and project such reviews as they communicate and of bulleted text for the introduction and requirements. Stakeholders involved in final address comments, metic ulously check discussion sections and text paragraphs for approval are the researchers, medico-legal content, propose solutions, and involve the the methods and results sections. Comm - team, intellectual property team, regulatory statistician or main author regarding any ents requesting input or suggestions to team, statistics head, and the clinical team queries. researchers or authors are put in the shell head.14,17,21 Submission of the manuscript to the draft. Once the shell draft is approved, the The line of reviews includes an in-house journal or conference involves a mock
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Deliverable Risk Impact Action Plan Conference abstract or Difficulties updating results Failure to disseminate • Publication team should plan oral presentation or poster from ongoing clinical trials key results of trial pre-presentation meeting with clinical or late-breaking clinical during conference lead to incorporate final data/results trial results
Poster and oral presentation Failure to capture important Poster with no scientific • Prepare ancillary (back-up)slides in for medical conference data due to limits on word impact, poster does not case of presentation count, slide count, convey the intended • In case of poster, prepare handouts or or poster size scientific message generate a QR code linked with additional information
Manuscript writing Minimal data sources Manuscript may lack • Ask for credible sources, especially provided by study sponsor impact the CSR of the study and arrange a kick-off meeting with the authors to discuss future directions and flow of manuscript
Manuscript writing Targeting high-tier journal Manuscript might be • Prepare a list of preferred journals with with high rejection rate rejected or major revisions their specifications (impact suggested by journal factor, rejection rate, circulation) from leading to delayed publication planning tools and discuss publication with authors • Draft a pre-submission query to journals regarding their interest to publish particular research work • Be ready with back-up journals and their submission guidelinesAbbreviations: CSR, clinical study report; QR, quick response.
Table 3: Example of a risk register for publication writing projects submission with the help of the publication an existing non-conformity and to avoid documentation is a final information dossier technical expert, preparation of a sub - recurrence of the same non-conformity. and includes all the relevant project-related mission package, and communicating with Corrective action comes into the picture logs, minutes-of-meeting reports, business the journal or conference secretariat. when issues have been logged or risks have emails, etc. These documents contain all been identified during audit findings, major important project specifications, decisions Monitoring and Control client reviews, etc. Preventive action on the made, and measures employed, as well as The monitoring and control phase of a other hand aims to avoid the initial information on the overall course of the project consists of risk management meas - occurrence of non-conformity by proactively project. Important aspects captured in the ures and review by the stakeholders. As implementing improvements. In brief, close-out dossier include risks and issues, Murphy’s Law says ‘Anything that can go CAPA acts as a solution to the issues or risks project quality, lessons learnt, and an overall wrong will go wrong’ and risks are encountered in the light of integrated quality analysis underlining achievements made associated with every project. Risk man- management. Gantt charts can be used to and pitfalls encountered during the agement is one of the most critical aspects note employee engagement and to track the execution. From the kick-off meeting to of project management. Hence the risk timelines of the project. One more way of project delivery, many lessons are learnt in identification and mitigation plan should tracking deviation in the process and keeping each phase of the process, which can be always be at the disposal of the project corrective measures ready is by employing a discussed and shared as a group. The manager. It is important to list all possible fishbone analysis (Ishikawa diagram). A mistakes made in the execution of the risks that may be encountered in the project fishbone analysis for deviations and their project and solutions offered therein go into and have an action plan ready so that the proposed solutions for a PW project are a knowledge base to be used for future risks do not become issues. An example of a given in Figure 4. reference. Special lessons learnt meetings are risk register is shown in Table 3.11,16,22 arranged to broaden the knowledge and Corrective action and preventive action Closure troubleshooting experience of the resources (CAPA) is another approach for managing Project closure involves close-out docu - involved in the project. risks.23 Corrective action aims at correcting mentation and review meetings. Close-out Preparing a data sheet comprising all
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 41 Auti / Pandey / Shah – Project management in medical publication writing
Fishbone analysis for publication projects (writers, authors, POCs, and project management)
Publication writer Authors • Prompt • Prompt communication/ communication/ regular follow ups from regular follow ups/ writer/POC (if required) problem solving Lack of • To categorise the communication Delayed response with no approach scientific inputs projects on the basis of • Weekly updates from with author/POCs timelines/difficulty level writer to respective for better project POC allocation • Back up writer for Project kept on High priority/no priority • Monthly meeting of each project back burner publications POCs/writers to discuss project details/support required from POC
Writer with multiple Providing incomplete data sources, projects is on leave setting high expectations of writers Timeline Measures taken/proposed slippages and solutions PUBLICATION WRITING increased Reasons for timeline slippage ovesight
Cannot decide Main outcomes Ad hoc requests author’s timeline
• Assessment of writers’ • Always send timelines workload before to authors/POCs accomodatig any ad POC is on leave Project is on hold before starting any hoc request project • Back up POCs • Write should start • Write should follow communication same process with all regarding their project POCs regarding Lack of support/ Journal response for in advance timelines and different work style major revisions • Write should check documentation status of their submitted manuscrips regularly Publication POCs Project Management
Figure 4: Risk mitigation fishbone analysis. Abbreviations: POC, Point of contact (Acts as a bridge between medical writer and authors and other stakeholders) detailed information about a project can pose significant problems due to the Project Management in compound (drug), such as the molecule ID, incomprehension of or misunderstandings Medical Publication Writing: history, generic term, drug class, and regarding requirements. Services of trans - Future Directions pharmacology, safety, and efficacy studies of lation agencies and interpreters can help The success of the project lies in the several that molecule, creates a knowledge base, overcome these issues. The project manager process improvement methods and diligent which can be utilised in the future. Closure should communicate clearly while interact - contribution of the assigned resources also involves keeping all documents in an ing with the POCs. The project manager promoting quick and smooth functioning. inventory, such as issue logs, logs of project needs to be able to negotiate effectively with Process improvement methods can further risks and mitigation strategies, and the vendors and should be endowed with good help expedite project delivery timelines and archiving of the published deliverable. interpersonal skills. Each resource working reduce costs. Capability maturity model We have discussed how projects are on the project should be given ample integration26 is a sophisticated process executed in medical writing organisations. freedom as well as accountability for the improvement plan that can be implemented Let us now see the various issues faced in seamless execution of the project. There by pharmaceutical companies as well as project management. Barriers to effective should be an efficient risk reporting system CROs in medical affairs or medical writing project management include communic - so that the risks do not become issues. In departments. In the case of CROs, capability ation hurdles, a lack of status-reporting addition, the project manager should be able maturity model integration appraisal measures, a low accountability culture, and to manage resources and resolve conflicts. additionally wins the confidence of the conflicts in decision-making. Communic - The behavioural and communication client and can help attract new projects and ation hurdles include language barriers or aspects of a manager are instrumental to the business for service industries. The global different interpretations of the intended progress of the project.24,25 hybrid delivery model, a relatively new message. Working with non-English speakers approach to carrying out project work in
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accordance with client specifications in publication practice for communicating engineering ethics. 1997;3(1):63-84. CROs, enables the seamless execution and company-sponsored medical research: 15. Johnson C, Green B. Submitting delivery of a project. It basically involves two GPP3. Ann Intern Med. manuscripts to biomedical journals: working teams, one offshore and the other 2015;163(6):461-4. common errors and helpful solutions. onsite, which coordinate with the client and 6. Van Noorden R. Global scientific J Manipulative Physiol Ther. each other to give effective output. The lean output doubles every nine years. 2014 2009;32(1):1-12. six sigma initiative is a business improve - [cited 2015 Nov 27]. Available from: 16. Atkinson R. Project management: cost, ment strategy that aims to improve team http://blogs.nature.com/news/2014/ time and quality, two best guesses and a performance by integrated efforts and 05/global-scientific-output-doubles- phenomenon, its time to accept other removing redundancy. This business strat- every-nine-years.html. success criteria. Int J Project Man. egy improves cross-functional teamwork in 7. John Hopkins University. Science 1999;17(6):337-42. any process driven service industry and also writing at Hopkins. 2015 [cited 2015 17. De Looze S. Are we nearly there? reduces the cost of poor quality resulting Nov 27]. Available from: Resource planning – step by step. from late delivery, customer complaints, http://advanced.jhu.edu/academics/ The Write Stuff. 2008;17(3):127–32. costs associated with mis directed problem graduate-degree-programs writing/ 18. Melnic AS, Puiu T. The management of solving, etc.27 There have been attempts at the-experience/science-writing-at- human resources within projects: the harmonising and implementing lean six hopkins/. structures of the project team, the sigma and PMBOK principles in pharma - 8. University of Chicago Graham School. responsibility assignment matrix. ceutical organisations.28,29 The future of Medical writing and editing. 2015 Economy Transdisciplinarity any product, process, or service lies in [cited 2015 Nov 27]. Available from: Cognition. 2011;14(1):476-84. innovation. Novel and innovative approaches https://grahamschool.uchicago.edu/ 19. Dubois B. Fostering collaboration. that minimise process hurdles and make noncredit/certificates/medical-writing- The Write Stuff. 2011;20(4):219-21. project execution smooth and error free are editing/index. 20. Globerson S. Impact of various work- the future ideals of project management. 9. Massachusetts Institute of Technology. breakdown structures on project MIT graduate program in science conceptualization. Int J Project Man. Conflicts of Interest and writing. 2015 [cited 2015 Nov 27]. 1994;12(3):165–71. Disclaimers Available from: http://sciwrite.mit. 21. Pololi L, Knight S, Dunn K. Facilitating The authors declare no conflict of interest. edu/. scholarly writing in academic medicine. The opinions expressed here are solely those 10.McGuigan GS, Russell RD. The J Gen Intern Med. 2004;19(1):64-8. of the authors and not necessarily those of business of academic publishing: 22. Williams TM. Using a risk register to SIRO Clinpharm Pvt Ltd. a strategic analysis of the academic integrate risk management in project journal publishing industry and its definition. Int J Project Man. References impact on the future of scholarly 1994;12(1):17-22. 1. Wager E. Publishing clinical trial publishing. E-JASL. 2008, 9(3). [cited 23. Motschman TL, Moore SB. Corrective results: The future beckons. PLoS Clin 2015 Nov 27]. Available from: and preventive action. Transfus Sci. Trials. 2006 Oct 27;1(6):e31. http://southernlibrarianship.icaap.org/ 1999;21(2):163-78. 2. Pakes GE. Writing manuscripts content/v09n03/mcguigan_g01.html. 24. Matthews JR, Matthews RW. describing clinical trials: a guide for 11. Project Management Institute. A Guide Successful scientific writing: a step-by- pharmacotherapeutic researchers. Ann to the Project Management Body of step guide for the biological and Pharmacother. 2001;35(6):770-9. Knowledge (PMBOK® Guide). 5th ed. medical sciences. 4th ed. Cambridge, 3. Sharma S. How to become a competent Newtown Square, Pennsylvania USA: UK: Cambridge University Press; 2014. medical writer? Perspect Clin Res. Project Management Institute, Inc.; 2013. 25. El-Sabaa S. The skills and career path 2010;1(1):33-7. 12. Fugh-Berman A, Dodgson SJ. Ethical of an effective project manager. Int J 4. Norris R, Bowman A, Fagan JM, considerations of publication planning Project Man. 2001;19(1):1-7. Gallagher ER, Geraci AB, Gertel A, in the pharmaceutical industry. Open 26. Team CMMI Product. Capability et al. International Society for Medical Med. 2008;2(4):e121-4. Maturity Model® Integration (CMMI Publication Professionals (ISMPP) 13. Sismondo S, Nicholson SH. SM), Version 1.1. CMMI for Systems position statement: the role of the Publication planning 101. J Pharm Engineering, Software Engineering, professional medical writer. Curr Med Pharm Sci. 2009;12(3):273-9. Integrated Product and Process Res Opin. 2007;23(8):1837-40. 14. Armstrong JS. Peer review for journals: Development, and Supplier Sourcing 5. Battisti WP, Wager E, Baltzer L, Bridges Evidence on quality control, fairness, (CMMI-SE/SW/IPPD/SS, V1. 1) D, Cairns A, Carswell CI, et al. Good and innovation. Science and (2002).
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27. Antony J. Six Sigma in the UK service organizations: results from a pilot survey. Managerial Auditing Journal. 2004;19(8):1006–13. 28. Herskovitz M. The harmonization of DMAIC and the PMBOK® guide for pharmaceutical lean six sigma projects. 2011 [cited 2015 Nov 27]. Available from: http://www. projectmanagement. com/articles/283581/The- Harmonization-of-DMAIC-and-the- PMBOK–Guide-for-Pharmaceutical- Lean-Six-Sigma-Projects. 29. Swanson SA. Winning pair: Integrating six sigma and PMBOK guide at an Never say never! organizational level. 2011 [cited 2015 Nov 27]. Available from: http://www.projectmanagement.com/ Returning to full-time articles/285914/Winning- Pair–Integrating-Six-Sigma-and- PMBOK-Guide-at-an-Organizational- employment after Level. freelancing Author information • Prashant Auti, MS (Pharm) has experience of working in the medical Alison McIntosh communications, HEOR, and ICON Clinical Research UK Ltd Abstract medical publication writing groups of Chandlers Ford Alison McIntosh successfully operated as various organisations. He has Eastleigh, Hants a freelance medical writer for 14 years supported scientific writing activities United Kingdom and gave up the ‘flexible lifestyle’ of a self- for several pharmaceutical giants. employed freelance medical writer to Prashant is currently associated with become a full time employee. She has the scientific writing and Correspondence to: joined a growing band of ‘decentralised’ communications team of SIRO Dr Alison McIntosh office workers and has become an Clinpharm Pvt Ltd, India. ICON Clinical Research UK Ltd employee of ICON Clinical Research, a • Rishabh Pandey, PhD is associated 6 Stoneycroft Rise full service, world-wide clinical research with the scientific writing and Chandlers Ford organisation (CRO). She has stepped communications team at SIRO Eastleigh, Hants from one end of the medical writing Clinpharm Pvt Ltd, India. He has United Kingdom, SO53 3LD spectrum to the other in terms of more than 20 publications to his Tel +44 (0)2380 688713 working arrangement and organisational credit in numerous peer reviewed [email protected] structure. The skills needed to work for a journals and experience as a journal large CRO align well with those of a reviewer. As a publication writer he freelance medical writer. Whilst major has supported the publication groups benefits of joining a large organisation of various pharmaceutical companies. have included colleagues to share the • Vatsal Shah, MD has vast experience workload, and well defined department in medical writing. He has been structures, new company jargon together involved in establishing and managing with the number of standard operating medical writing departments across procedures have been a more challenging different pharmaceutical companies experience. in India. He is currently working as chief operating officer at SIRO Clinpharm Pvt Ltd, India. I have been a medical writer for the pharmaceutical industry for 20 years. My
44 | March 2016 Medical Writing | Volume 25 Number 1 medical writing career began when, after time employee again. My employer is ICON documents of a high standard. Since I had working as a postdoc, I became a full time Clinical Research, a full service, world-wide also been exposed to a variety of different employee with Wellcome (now Glaxo - clinical research organisation (CRO). This document types, for me it was also import - Smith Kline). After 5 years as an employee, change in status allowed me to truly step ant that I maintained an exposure to I made the momentous decision to become from one end of the medical writing regulatory writing whilst also continuing to a freelance medical writer and found gainful spectrum to the other in terms of my emp- have the opportunity to write medical employment in this capacity for 14 years. loyment arrangement and organisational communications documents. Most of my freelance years were during structure. I have now joined a growing band of what I like to refer to as the ‘pre-blog era.’ As At first glance, joining a large CRO may ‘decentralised’ office workers working from such, I documented my medical writing have seemed like a strange move for home on a permanent basis. When I first journey in articles published in the EMWA someone who had worked as a sole trader became a freelance medical writer the journal. My first ever EMWA article was for such a long time, but for some time opportunity to pursue this type of working entitled “Medical Writing at Home” and previous to making the move, I had felt that arrangement was limited, not least because covered my significant change in direction, I needed new challenges. When I con - of the lack of reliable home internet relaying important first steps along the road sidered what I wanted to achieve, working facilities. In 2000 these were primitive to say of a freelance medical writing career.1 for a CRO seemed to me like a natural the least. Who among us remembers the Alongside this, I documented my first progression as I thought the freelance skills long cables that were originally needed to attendance at an EMWA conference,2 my that I had built up were ideally suited to this connect a computer to the phone line for experience of developing an EMWA environment. dial up internet services using AOL as a workshop,3 and how my years as a freelance During my 14 years as a freelance service provider? These limited internet medical writer progressed and my medical medical writer I had essentially operated as connections made downloading a docu - writing experience developed.4, 5 a CRO in miniature (Table 1 overleaf). I had ment bigger than 1 or 2 pages an imposs - a broad client base, and I had learned how to ibility – and sometimes even 1 or 2 pages Setting off on a New Medical provide a service to these clients that met took hours! This limitation is definitely a Writing Journey their requirements and needs. I was adept at thing of the past. Working from home A new episode in my medical writing meeting tight deadlines and being flexible in nowadays means you have access to journey began in June 2014 when I gave up terms of working arrangements. Through everything you would have in the office, the “flexible lifestyle” of the self-employed, the years I had gained the ability to trans - including all the servers and back-up freelance medical writer to become a full form client requirements into well written systems you expect from working for a large
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 45 McIntosh – Never say never!
Individual Skill Large CRO Freelance MW (mini CRO) Broad client base X X Interaction with many different clients X X Understand the individual needs of clients X X Conflicts of Interest and Developing new clients X X Disclaimers Understand what is required to meet agreed deadlines X X Alison McIntosh is an employee of ICON Project management skills X X Clinical Research UK. She is also a work - Awareness of budgets X X shop leader for EMWA, a section editor Awareness of time required to completed writing tasks X X of Medical Writing and has served on Different types of medical writing a, b XXthe EMWA Professional Development Regulatory X X Committee. Medical Communications X X a This skill is based on the medical writer’s personal experience and the different documents References they have written or audiences they have written for. 1. McIntosh A. Medical Writing at Home. b Not all clinical research organisation offer the ability to write both regulatory and medical The Write Stuff. 2001;10(4):82-83 communications documents. (available from http://www.emwa.org/ documents/journal/TWS/ Table 1 Matched Skill Set of Freelance Medical Writer and Clinical Research Organisation The%20Write%20Stuff_Vol%2010_ No%204_ 2001.pdf). 2. McIntosh A. CTD Seminar in Brighton. company. Everything is completed online learning facilities available to me in the The Write Stuff. 2002;11(1):9-10 with only an occasional visit to the office workplace together with other CPD (available from http://www.emwa.org/ required. opportunities. There is just not enough time documents/journal/TWS/ in the working day to avail myself of all the The%20Write%20Stuff_ Has the Change been Positive? possibilities on offer. Vol%2011_No%201_ 2002.pdf). Of course, there are pros and cons 3. McIntosh A. Developing a Workshop associated with making what many might Advice to Others? for the EPDP. The Write Stuff. consider a ‘giant leap’. Major positives are My main advice to all medical writers, and 2002;11(3):64-65 (available from friendly colleagues with whom I can discuss not just those who are working in a freelance http://www.emwa.org/documents/ challenges and share the workload. The capacity, is to always keep your options journal/TWS/TWS%202002%203% problem of conducting independent quality open, and do your utmost to grow 2011.pdf). control of documents has also disappeared professionally. As a freelance medical writer, 4. McIntosh A. Round Robin. The Write as there is a distinct process in place to regularly attending EMWA conferences to Stuff. 2005;14(1):19-20 (available from achieve and verify these important stages of keep up to date with advances and changes http://www.emwa.org/documents/ document development. There are well in the industry was of enormous importance journal/TWS/TWS%202005% defined department structures and for the to me. Playing an active part in EMWA, the 201% 2014.pdf). first time in around 15 years I found myself organisation, can pay huge dividends not 5. McIntosh A. Broad-Spectrum Medical looking at an organogram with my name on only when looking for opportunities as a Writer: Nature or Nurture? The Write it. Joining a large organisation also exposes freelancer, but also if you decide to change Stuff. 2009;18(1):7-8 (available from you to company jargon and many, many direction at a later stage in your career. http://www.emwa.org/documents/ standard operating procedures (SOPs). The Overall, my change in career direction journal/TWS/TWS%202009%201% sheer number of SOPs was one of the most has provided me with new challenges as a 2018.pdf). challenging features of joining a large CRO, medical writer and increased my prof ess - but after more than 1 year in the job this ional experiences. I understand that it is not aspect has become routine in nature. a direction that all freelance medical writers Author information Continuous professional development will choose to follow and is heavily Alison McIntosh has been a medical writer (CPD) is something that we all have to be dependent on factors that are specific to the for 20 years. She was initially employed by aware of and pursue. As a freelance medical person concerned. However, for me it has Wellcome (formerly GlaxoWellcome, now writer you are responsible for organising and been the right move at the right time. GlaxoSmithKline) for 5 years, before paying for your own CPD, and committing Although I have fewer holidays, and may becoming a freelance medical writer and to regularly attending EMWA conferences have a little less flexibility in the work I trading as AAG Medical Writing for 14 over the years has allowed me to keep undertake, I had my first paid holiday in over years. Her broad medical writing abreast of new developments in the 14 years and I think it was all the more experience covers both regulat ory writing pharmaceutical industry. I now have an relaxing because of this. and medical communic ations. employer that ensures there are on line
46 | March 2016 Medical Writing | Volume 25 Number 1 Fifth EMWA freelance business survey
Jonathan Edwards1, Alistair Reeves2 and Adam Jacobs3 1 Macclesfield Medical Writing Ltd, Macclesfield, UK 2 Ascribe Medical Writing and Translation, Wiesbaden, Germany 3 Premier Research, Wokingham, UK
Correspondence to: Jonathan Edwards Macclesfield Medical Writing Ltd. Macclesfield, UK [email protected]
Abstract Following surveys in 2003, 2007, 2010 and 2012, the fifth EMWA Freelance Methods icipants were classified as doing mainly Business Survey was conducted in 2015. Questionnaire design and distribution regulatory work, mainly med comms work, 181 respondents, most based in Europe, The EMWA Freelance Team developed the or a mixture of the two, as follows. The completed the survey. The findings 2015 web-based survey, based on the 2012 percentage of time spent working on docu- indicate that freelance medical writing instrument. Individual questions were ments that were clearly regulatory (summ - and related activities continue to offer a revised to reflect feedback from EMWA ary documents, protocols, CSRs, other varied and potentially lucrative business freelancers, to take account of an interim regulatory documents, and SOPs) or clearly opportunity. The responses received survey on types of regulatory documents med comms (journal articles, marketing indicate a wide range of types of work worked on by freelance writers, and changes materials, presentations, or product inform - and client, from niche opportunities to in the medical writing field. The resulting ation) were summed to give a total for each more traditional medical writing questions differed considerably from type. If the percentages of each type were activities. In addition, freelancing offers previous years, so historical comparisons within 10% of each other, participants were unique flexibility, as indicated by the were generally not possible. To enable classified as doing both kinds of work, range of hours worked. Chargeable rates comparison across surveys, the questions on otherwise they were classified as doing the have been stable since the first survey in chargeable rates were not changed. type of work with the larger percentage. 2003, and it appears that the freelance The 10-question survey was produced Where participants had given rates in British environment remains a healthy place on SurveyMonkey and was available online pounds, these were converted to euros at the within which to operate. from mid-January 2015 to mid-March 2015. rate prevailing on 27 September 2015 (£1 = EMWA sent an email with the survey web €1.35). link to all members and an announcement Introduction was posted on EMWA’s LinkedIn page and Results and Discussion This fifth survey follows those conducted in social media, with reminders sent out using Number of responses and geographical 2003, 2007, 2010 and 2012.1,2,3,4 the same channels. The survey was open to location of respondents and their clients The survey has developed considerably, anyone conducting freelance medical 181 respondents participated in the 2015 from the initial paper-based questionnaire writing activities in Europe, including non- survey, an increase of almost 50% compared distributed at the Freelance Business Forum members of EMWA. with 123 in the previous survey in 2012. held at the EMWA spring conference in Almost two-thirds (115, 63.5%) were based 2003, to an online system shared with all Statistical methods in a European country and undertook work potential respondents via SurveyMonkey. Data were analysed using Stata version 13.1. for clients in different countries. A smaller The number of respondents has grown All data are presented using descriptive proportion (54, 29.8%) of respondents were almost three-fold, from 63 for the first statistics only. based in Europe and worked only with survey in 2003 to 181 in 2015. For the analysis of hourly rates, part - clients in their own country. Few (12, 6.6%)
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respondents were based outside Europe and Number of hours worked Sources of work Response had European clients. Respondents were asked how many hours average (%)a they worked per week, based on typical Longstanding customers 56.5 Employment status and EMWA workload over the last 3 years (Table 1). It Referrals from colleagues 17.2 membership is interesting to note that slightly less than Referrals from customers 14.5 Almost two-thirds (110, 62.5%) of resp - half (81, 46.3%) of respondents worked for Professional or social networking 11.6 ondents were full-time freelancers, and most more than 30 hours per week, but almost sites of the remainder (57, 32.4%) were part-time two-thirds (62.5%) of respondents consider Own advertising, including 6.1 freelancers (Figure 1). Only a small themselves to be full-time freelancers. In the own website proportion (9, 5.1%) of respondents were context of a standard working week of EMWA Freelance Directory 2.3 employed by a company and also undertook approximately 40 hours as an employee, it Other 9.4 some freelance work. All emp loy ment appears that freelancing may offer a a Average percentage of total work categories were well represented by EMWA favourable work-life balance compared with undertaken, based on typical workload members and non-members. the ‘employed’ sector. over the last 3 years
1.7% Hours per weeka Response count (%) Table 2. Sources of work (N=163) 3.4% 1–10 8.6 11–20 16.6 21–30 28.6 from long-term customers. Referrals from 12.5% 31–40 30.3 colleagues and customers also provided for 41–50 13.1 a large proportion (31.8%) of work 39.2% >50 2.9 undertaken. The pattern of sources of work a Average number of hours, based on has been similar in all surveys so far. These 19.9% typical workload over the last 3 years findings are not surprising, as interpersonal relationships are the building block of any Table 1. Number of hours worked (N=175) service business. However, other more ‘virtual’ approaches, including websites and 33.2% professional and social networking sites, Sources of work and work providers provided for approximately 20% of work on Respondents categorised sources of work average, and therefore are also of consid - (Table 2) and providers (Table 3). erable value when building a broad and ■ A full-time freelance writer or editor By a considerable margin, the most stable client base. who is an EMWA member 39.2% significant source of work (56.5%) came The most significant providers of work ■ A full-time freelance writer or editor who is NOT an EMWA member 23.3% Work providers Response average (%)a ■ A part-time freelance writer or editor Medical communications agencies 43.2 who is an EMWA member 19.9% Research-based pharmaceutical companies 27.9 ■ A part-time freelance writer or CROs on behalf of any of the above 13.4 editor who is NOT an EMWA Academic institutions or academia-based individuals 12.2 member 12.5% Publishing companies 10.3 ■ Employed by a company (full- or Medical device companies 6.9 part-time), and also do freelance Medical writing companies 3.9 writing work, and an EMWA Biotech companies 3.5 member 3.4% Non-profit organisations 3.0 ■ Employed by a company (full- or Generic companies 2.8 part-time), and also do freelance Work placement agencies 2.4 writing work, but NOT an EMWA Any other sponsor (eg, investigator-led research groups) 1.9 member 1.7% Other 3.6 aAverage percentage of total work undertaken, based on typical workload over the last 3 years Figure 1. Employment status and EMWA membership (N=176) Table 3. Work providers (N=157)
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may reflect that this survey was more widely aAverage percentage of total publicised on LinkedIn and social media. a 70 work undertaken, based on typical workload over the Types of work undertaken 60 last 3 years Respondents categorised their work by 50 broad ‘type’ (Figure 2) and also more specifically by document type (Table 4). 40 Writing constituted the most significant portion of work (62.3%), with editing 30 (19.1%) and consultancy work (10.3%) also providing significant amounts of work. 20 Opportunities also exist in the fields of
Average % of time spent on activity Average quality control, translation, proof-reading 0 and training. Slightly over half of all work can be work Other events Proof- categorised under the general headings of control Editing reading Quality Writing Training Training ‘medical communications’ and ‘public at - Electronic Electronic publishing Translation
Consultancy ions’, including articles for scientific journals and congresses, product information and Figure 2. Types of work undertaken (N=156) educational materials for patients and healthcare professionals. Approximately one were medical communications agencies also exist in the biotech, generics and quarter of work fell under the heading of (43.2%), research-based pharmaceutical medical device fields. This was the first ‘regulatory writing’, including work for companies (27.9%). Contract research survey where the proportion of providers regulatory submissions, clinical and non- organisations (CROs), academia and pub- working mostly in the area of medical clinical study reports and protocols, and lishing comp anies each provided for more communications (56.4%) exceeded those patient safety documentation and other than 10% of work on average. Opportunities doing mostly regulatory work (22.1%). This annual updates. ‘Presentations’ also comp -
Type of document Response average (%)a Articles for scientific journals and the scientific press 32.2 All other (non-protocol-related) supporting documentation contributing to non-clinical 9.8 and clinical study reports, and the reports themselves Marketing materials, including congress materials and proceedings 9.7 Presentations 9.7 Summary documentation for regulatory submissions, eg, clinical overviews and summaries 8.1 of efficacy and safety (including non-clinical), including regulatory prescribing information (eg, SmPCs) Educational materials for patients and health professionals, including audiovisual media 6.8 Preparatory documents for non-clinical and clinical trials including study protocols and supporting documentation 5.3 Product information for marketing purposes, including product monographs 3.9 Consultancy documentation 2.2 Training documentation 2.0 Other regulatory documents, eg, variations, PBRERs, RMPs, Annual Reports, responses to authority questions 1.9 Websites 1.9 Medical and scientific textbooks 1.5 Standard operating procedures 1.0 User manuals for devices 0.3 Other 5.4 aAverage percentage of total work undertaken, based on typical workload over the last 3 years. Abbreviations: PBRER Periodic benefit-risk evaluation report; RMP Risk management plan; SmPC Summary of product characteristics
Table 4. Types of documents authored (N=148)
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Type of work activity N Minimum 25th Median 75th Maximum addition, freelancing offers unique flex - percentile percentile ibility, indicated by the range of hours Writing (total) 134 0 68 78 90 384 worked. Chargeable rates remain stable, and Med Comms writing 90 0 66 75 82 384 it appears that the freelance environment Regulatory writing 39 48 69 90 104 160 remains a healthy place within which to Editing 108 0 55 70 83 384 operate. Translation 37 0 30 60 80 160 We hope that these data will allow you to Proof reading 53 0 40 60 87 384 assess your own business model, client Quality control 51 0 50 70 83 139 profile and chargeable rates, so you can Consultancy 63 0 66 83 110 186 make the most of your own freelancing in Electronic publishing 21 0 0 62 79 139 the future. Other 21 0 0 45 71 139 EMWA would like to thank all resp - Training 16 50 70 84 125 150 ondents for taking the time to contribute to Training preparation 12 55 68 95 115 150 this survey. Training (half day rate) 14 200 280 385 500 800 Training (whole day rate) 21 350 560 840 1000 1750 References aAll rates are in euros per hour 1. Reeves A, Drees B. EMWA Freelance and Small Business Survey 2003. Table 5. Chargeable rates in euros, by type of work activity TWS 2004;13(1):11-13. 2. Reeves A, Hamilton S. EMWA Freelance Business Survey 2007. rised about 10% of work undertaken, by peak, but this may reflect there being fewer TWS 2007;16(3):138-140. ‘document’ type. respondents in previous surveys. 3. Reeves A. Third EMWA Freelance Business Survey 2010. Hourly rates Differential charging by client type TWS 2010;19(2):147-149. Respondents provided hourly rates in euros, Data were also summarised for hourly rates 4. McDonough A, Billiones R, Hamilton which are summarised by the type of work by type of client, with respondents S. Fourth EMWA freelance business activity undertaken in Table 5. Whilst indicating whether they charged a particular survey 2012. Medical Writing minimum and maximum values can be type of client more, less or the same as their 2013;22(1):67-77. misleading, presentation of 25th, 50th and ‘regular’ rate (Figure 4). Overall, it appears 75th percentile values provides a more that most writers charge most types of useful overview of rates charged. clients the same rate. The main exception to Unsurprisingly, training work demands this observation is that almost half (40/90, the highest premium, with daily rates in 44.4%) of respondents indicated that they excess of €840 (50th percentile) not charged research-based pharmaceutical uncommon, and with rates rising up to companies a higher-than-usual rate. Con - Author information €1750. Of course, this high rate is likely to versely, some types of clients were offered Jonathan Edwards: after 13 years be offset by the fact that opportunities for lower rates by some respondents, most working as an ‘employed’ medical writer such work may be more sporadic than other notably academic clients, non-profit organ - in a med comms agency and more activities. Writing work also tends to be isations and publishing companies, although recently in large pharmaceutical comp- charged at higher rates than most other the difference was much less pronounced any, Jonathan has recently set up a UK- types of activities, with regulatory writing than for the pharma companies. based freelance medical writing business. commanding a higher median hourly rate at ([email protected]) €90 than med comms work at €75. The Conclusion Alistair Reeves is a freelance author’s median rate for consultancy work was €83 Our survey shows that freelance medical editor, translator and trainer based in per hour. writing and related activities continue to Germany. ([email protected]) It is of note that hourly rates have offer a varied and potentially lucrative Adam Jacobs is a senior principal remained stable during the 12 years since business opportunity. The responses rec - statistician with Premier Research and the first survey in 2003 (Figure 3). Con - eived indicate a wide range of types of work used to be a medical writer. You can find sultancy work appears to be the exception, and clients, including niche opportunities in him on Twitter at @statsguyuk. with rates consistently lower than the 2003 addition to more traditional activities. In
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110
100
90
80 Median hourly rates in euros hourly rates Median 70
60
50 2003 2007 2010 2012 2015 ■ Writing ■ Editing ■ Proof-reading ■ Quality control ■ Consultancy work
Figure 3. Median hourly rates 2003–2015 in euros
Non-profit organisations
Publishing companies
Academic clients
Medical writing companies
Med Comms agencies
CROs
Other sponsors
Medical device companies
Generics companies
Biotech companies
Research-based pharma 0 10 20 30 40 50 60 70 80 90 Number of respondents (for the client type in questions)
■ Charge the same ■ Charge less ■ Charge more
Figure 4. Differential charging by client type (N=141)
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52 | March 2016 Medical Writing | Volume 25 Number 1 XXXX – XXX
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 53
Journal Watch SECTION EDITOR ✒ Hervé Maisonneuve ● [email protected] From the Editor-in-Chief: Journal Watch is the re-birth of a previous column edited by “ Are meta-analysis simple Nancy Milligan. We are happy to welcome Hervé Maisonneuve, MD as the new Section works, office-based, cheap, Editor for Journal Watch. Hervé is a contributing editor for several scientific journals and time-efficient with chances regularly teaches medical writing in hospitals and universities in France. The new version to be highly cited? of Journal watch will be based on his French-language blog Rédaction Médicale et Scientifique, available at http://www.redactionmedicale.fr. In an article recently published in Medical “ Hypothesis, Giovanni Tebala, a surgeon, warned about a trend in current research Journals should publish referee reports and respond to for researchers to move from performing well-founded concerns about papers after publication randomised clinical trials to systematic reviews and meta-analysis. He warned According to an article by Nicolair Slavov published in the November 11 issue of eLife, that “If we are unable to invert this trend, referee reports are helpful and hiding them is an enormous waste. The author encourages in the future we will have a growing post-publication debates and for journals to take the lead in considering non-anonymous number of synthetic studies utilising comments posted on electronic platforms. Three controversial reports—one that a bacterial someone else’s original data and fewer DNA sample contained arsenic instead of phosphorous, one that RNA sequences contain raw data to base our knowledge upon.” widespread edits or changes from the corresponding DNA sequences, and one on stimulus- Reference: Tebala GD. What is the triggered acquisition of pluripotency — have shown that post-publication comments offer a future of biomedical research? Medical fast and efficient method for raising concerns about potential problems in published papers. Hypothesis 2015;85(4):488-490. Reference: Slavov N. Making the most of peer review. eLife 2015;4:e12708.
The COMPARE Project
The COMPARE project is an Oxford- JAMA, Lancet, and New England Journal of trials were considered “perfect”, while the based group (http://compare-trials.org/) Medicine) to see if the findings have been remaining had a total of 355 outcomes that is tracking “switched outcomes”. misreported by comparing each clinical not reported and 336 new outcomes that They are systematically checking every trial report with its registry entry. Results were silently added. Unreported or added trial published in the top five medical are updated weekly, and as of January 6, outcomes are reported to the journal so journals (Annals of Internal Medicine, BMJ, 2016, they had checked 66 trials. Only 9 that readers are aware of the problems.
54 | March 2016 Medical Writing | Volume 25 Number 1 First data on the reproducibility of research published in Science
A huge effort is under way to reproduce 100 experiments published by three prestigious American psychological journals (https:// osf.io/ezcuj/). The effort, supervised by the Center for Open Science at the University of Virginia (US), is supported by 250 researchers at 125 foundations in the US. As reported in the August 28th issue of Science, although 97% of original studies had statistically significant results, only 36% had statistically significant results when they were reproduced. In 47% of the cases, the original effect sizes were in the 95% confidence interval of the replication effect Restoring study 329: re-analysis of a paroxetine trial with the size, and only 39% of effects were sub - same data with opposite conclusions jectively rated to have replicated the original result. The authors concluded that “if no Study 329 was a randomised, controlled trial on the efficacy and harms of paroxetine and bias in original results is assumed, imipramine in the treatment of adolescent major depression published in the Journal of combining original and replication results the American Academy of Child and Adolescent Psychiatry in July 2001. The original paper left 68% with statistically significant effects.” concluded that “Paroxetine is generally well tolerated and effective for major depression A similar same effort is being carried out in adolescents” and found that “The response to imipramine was not significantly for cancer biology (https://osf.io/e81xl/ different from placebo for any measure.” The article was ghostwritten and largely wiki/home/), although results have not yet criticised, with a variety of anomalies spotted by researchers. A reanalysis of the original been published. study, recently published in BMJ, was carried out under the Restoring Invisible and Reference: Open Science Collaboration. Abandoned Trials initiative “to see whether access to and reanalysis of a full dataset from Estimating the reproducibility of a randomised controlled trial would have clinically relevant implications for evidence psychological science. Science 2015 based medicine.” The authors of the re-analysis concluded, ”Neither paroxetine nor high (28 August);349:6251. dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs.”
Reference: Keller et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomised, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7): 762-72. Doshi et al. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013;346:f2865. Le Noury. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
The HAP score for granting authorship of large multi-center trials
In an article relevant to the current issue of enrolment, follow-up, and adherence, as well Reference: Medical Writing, David Whellan describes a as participation in committees and other Whellan DJ et al. Authorship in a new system for attributing authorship, the trial activity” and “was designed to enhance multicenter clinical trial: The Heart Failure HF-ACTION Authorship and Publication rate of dissemination, recognise investigator – A controlled trial investigating outcomes (HAP) score. The HF-ACTION study was contributions to the successful conduct of of exercise training (HF-ACTION) a randomided clinical trial that examined the trial, and harness individual expertise in authorship and publication (HAP) scoring the efficacy of exercise training as a supp - manuscript generation.” They admit that systems results. Am Heart J 2015;169:457- lem ent to standard care in heart failure although it is not without limitations, the 463.e6. patients The score assigns points according system may be useful as a starting point for to “investigators’ participation in trial authorship decisions in multisite trials.
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 55 SECTION EDITORS In the Bookstores ✒ Alison Mcintosh ● [email protected] ✒ Stephen Gilliver ● [email protected]
The Elements of English Editing: A Guideline to Clear Writing by Lee Ann Weeks and Ann Bless; Scientific Editing Service, 2013. ISBN: 978-90-820504-0-0. €10.50. 71 pages.
to; and insufficient differentiation of step-by-step way; the authors provide an unfamiliar information, where writers example text, indicate the problem, and mistakenly assume the reader is familiar with provide a solution to the problem followed information that is not yet been introduced. by a revised text. A valuable feature of this It also highlights the muddled use of chapter is that the advice given is broad and singular and plural, mixed use of positive not limited to a single document type. Thus, and negative state ments, inconsistent term - the problems covered have implications for inology, insuffic ient repetition, and unclear regulatory and medical communication pronouns, all of which can contribute to documents. cumbersome and ambiguous reading. Chapter 3 looks at editing text which has Substantive editing at the paragraph level been translated, in particular the need to ensures that each paragraph presents a single ensure that sentences are accurate and In The Elements of English Editing: A Guide- cohesive idea. The authors highlight errors complete and that the correct wording is line to Clear Writing, authors Lee Ann Weeks that writers are particular prone to, including used. The chapter concludes with four and Ann Bless have combined their 50 years incorrect distinction of paragraphs, not helpful approaches to revising translated of experience to create a concise, 71-page defining the topic of the paragraph in the text: 1) setting the document aside before book which introduces readers to the first line, misuse of transitional statements self-editing, 2) checking the translated text language editing process. This book is to improve the flow between multiple points against the source, 3) having someone else divided into six chapters covering topics within a single paragraph, and incorrect check the translated text against the source, such as substantive editing, translational ordering of information within the para - and 4) having someone else edit. For writers editing, copy editing, proof-reading and on- graph. Lastly, the authors explain how the whose first language is not English, or who screen editing. It provides practical inform- use of parallel terminology, where writers regularly translate text, reading this chapter ation to anyone entering or currently in the use different words to describe the same is particularly worthwhile. editorial profession, as well as a useful tool thing within a single paragraph, increases the Chapter 4 discusses the need for copy for medical writers and writers who translate complexity of the text and can affect its editing and the distinction between copy text on a regular basis. readability. editing and proof-reading. The authors Chapter 1 introduces the reader to the Substantive editing at the sentence level define copy editing as the process by which rationale behind the book, references various is similar to editing at the paragraph level. the text is checked for accuracy and con - institutes, societies and other organisations Here, the editor checks for a multitude of sistency but also whether the text layout approach to editing and outlines the features including incorrect use of pro - conforms to specific guidelines. In part - authors’ approach and what to expect from nouns, incorrect ordering of information, icular, it relates to the visual characteristics the subsequent chapters. correct presentation of parallel ideas, of the text and includes reviewing headings, Comprising of 28 pages, chapter 2 forms inappropriate use of connective words, bullet points, spelling, punctuation, the major part of this book and provides a empty wording, passive wording and parentheses, references, figures, tables and general overview of substantive editing, ambiguity in the text, to name but a few. In appendices. This chapter discusses each whether it is at the text, paragraph, or the final section of this chapter the authors characteristic and highlights some basic sentence level. At the text level, the role of discuss each feature of editing at the writer errors with more examples of editor is to check for a main topic statement paragraph level and provide practical advice problematic text and suggested revisions. which has logic and cohesion followed by a to ensure the flow of the text is logical, Chapter 5 discusses the role of the proof- concluding statement. The authors cover a coherent, and unambiguous. reader in reviewing documents. The proof- range of common errors which require Overall this chapter is well-structured reader reviews the final version of the text, substantive editing. These include, but are and informative; throughout the chapter the which can either be compared against a not limited to, unfulfilled announcements authors provide relevant examples of preceding version or without reference to and missing markers, where writers fail to problematic text which requires revision. the previous version and as such is a “blind” discuss a topic that they claim they are going These examples are described in a logical review of the document. The proof-reader
56 | March 2016 Medical Writing | Volume 25 Number 1 provides an essential role in highlighting and a useful editor’s checklist consisting of nature. However, at €10.50, it does offer formatting error, inconsistencies, omissions 30 key points an editor needs to check at the value for money as a useful reference book. or typos that may have arisen after multiple text, paragraph and sentence levels. You may not find this book in bookstores, editorial review stages and typically uses a Other reviewers have complimented this but you can get it from the following set of symbol to denote changes; which are book on its practicality and I would echo websites: www.sciencewriting.nl/book/ and presented in this chapter. It also provides that sentiment. From a writer’s perspective, www.annbless.com. information on how to effectively edit a it is a useful guide to prevent unnecessary document “on-screen” using track changes last-minute editing of documents. Reviewed by Nicholas Churton and comments, as well as the benefit of Admittedly, many of the topics covered are Medical Writer using macros and comment codes. basic and are by no means dealt with Clinical Research Services, This book concludes with some final comprehensively. Thus, a seasoned medical ICON, Eastleigh, UK remarks in chapter 6, a reference section, writer may consider the content second [email protected]
Visual Complexity: Mapping Patterns of Information by Manuel Lima Princeton Architectural Press, 2013. ISBN: 9781616892197 (paperback). 21.99 GBP; 272 pages.
before, the aim of data visualisation has understand big data. In this way, visual changed from simple data presentation to representations can facilitate the perception the representation of multi-dimensional of patterns, connections, and structures. relationships. Computer scientists, artists, Interestingly, Visual Complexity reveals and writers often work hand in hand to find that besides aiming for efficiency and clarity, ways to represent relationships between information visualisation designers aim to more dimensions of data than is possible communicate their ideas about data, making with two-dimensional displays such as bar statements and evoking particular emotions charts and scatter plots. in the viewer. Although Lima shows that the standard Whereas this is clearly a no-go for graphical language, which consists of points, regulatory writing, it might be an interesting lines, and curves, can be found in novel consideration for communication with lay Making a pool of knowledge available to lay information visualisation techniques, he audiences. Actually, as a medical writer, you audiences can be challenging and often also points out that aesthetics and might already have been using the new invites the following question: How is contemporary design features have in recent graphical visualisation language without information understood, processed, and years become a major aspect of data knowing it. Think about it: An integral part presented? Manuel Lima, the New York- visualisation. To illustrate this, he highlights of medical communication is the based founder of the network visualisation 15 basic types of network diagrams, ranging visualisation of complex data through (flow) platform visualcomplexity.com, investigates from arc diagrams to flow charts and charts, pictograms, and infographics. this question in his book Visual Complexity: spheres. While Lima explores how different Communication with lay audiences is often Mapping Patterns of Information. Visual strategies to map information work, he does facilitated by visual aids and representation Complexity provides a collection of essays not provide insights into new visualisation of large data sets through multi-dimensional and 100 examples of information techniques. For those interested in actual visualisations should clearly be considered visualisation from the field’s leading visualisation techniques, The Visual Display for this purpose. professionals. It becomes obvious that of Quantitative Information by Edward Tufte As Lev Manovich, author of the book information visualisation has evolved in provides sophisticated guidance on this The Language of New Media, sums it up in recent years and now goes far beyond the topic. the foreword to Visual Complexity:‘We seek standard line charts, pie charts, and box Visual Complexity focuses on the to represent, in order to understand.’ plots that many of us routinely produce. beautification of big data through an Manuel Lima’s aim with this book was to innovative mix of art and design. Lima decode trends and technologies of data argues that information visualisation has representation so that readers can become the modern language of data understand and appreciate this fast evolving representation in the twenty-first century. Reviewed by Carola Krause field, which emerged with the rise of the Whereas data visualisation is widely used as Freelance Medical Writer information age. Since we now have to a tool to present data, Lima suggests using codeX represent considerably more data than visualisation techniques in order to [email protected]
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 57 The Webscout
Authors and Authorship
This issue of Medical Writing focuses on programme in autumn 2014. As explained authors and authorship, but where, in fact, SECTION EDITOR in the blogs Web Engine Land (http:// did the term “authorship” come from? The searchengineland.com/authorship-dead- Karin Eichele term first appeared in the early 18th century. ✒ long-live-authorship-217209) and Buzz - ● [email protected] In a paper presented at the Annual Meeting sumo (http://buzzsumo.com/blog/author- of the National Council of Teachers of authority-influence-content-marketing- English and available online at http://files. print and the digital culture. This fits interview-j-d-metz/), this initiative could eric.ed.gov/fulltext/ED266481.pdf, Lisa perfectly fits with Lisa Ede’s explanation that have helped authors build their “author Ede describes the historical perspective and common understanding of what authors authority”, which aims to help authors development of the concept of authorship. and authorship mean changes as culture generate credibility and awareness so that She explains that authorship is a complex evolves. Of course, the meanings can differ their content is read. construct and reflects the contemporary between literary works and academia. Modern communication allows not only culture. Wikipedia defines the term “academic spreading of your ideas but also interaction Apropos history: Did you know that it is authorship” as the way “by which academics between you and your community, who can a matter of debate that Shakespeare really is communicate the results of their scholary leave you comments and messages or add the author of the works accredited to him? work” (http://en.wikipedia.org/wiki/ their own ideas. So what about the According to the Sheakesperean Authorship Academic_authorship). authorship of user-generated content on, for Trust (www.shakespeareanauthorshiptrust. In 2011, Google created a special web example, your webpage or blog? What looks org.u), whether he is the true author of his feature named “authorship”, connecting each like a simple issue turns out to be much works has been debated for hundreds of piece of content to an author profile with more complex. Do you want to reuse years. individual biographical information and content posted by your community? What According to a presentation entitled photograph. The idea was to influence page do you have to consider in terms of liability? “A Visual History of Authorship” (http:// rankings based on the reputation of its Who is responsible for the content? If you prezi.com/wd7yqxxkl-qw/visual-history-of- authors using digital signatures. Because of declare that you own all content posted on authorship/), the history of authorship can a lack of success and the sinking prominence your page including those of your followers, be split into three cultures: the pre-print, the of G+, Google cancelled the authorship than you might also be liable, for example, for copyright infringement. Some inform - ation and guidance can be found on the blog Legal to English (http://outsourcedassociate. com/owns-user-generated-content-site/). Finally, what do social networks have to say? Instagram (www.instagram.com/explore/ tags/authorship), for example, gives an idea of how people are visualising the term “authorship”. This can be a source of inspiration. Different pictures of reading, writing or books from daily life might encourage you to further explore and stumble over interesting people and interesting ideas. Did you like this Webscout article? Do you have any questions or suggestions? Please feel free to get in touch and share your thoughts.
Karin Eichele and Marc Briele mediwiz [email protected]
58 | March 2016 Medical Writing | Volume 25 Number 1 SECTION EDITOR Regulatory Writing ✒ Greg Morley ● [email protected] Authorship issues in regulatory documents
When medical writers discuss authors and involved in the drafting process, and have the source data in detail. Potential conflicts authorship – the theme of this issue of critically reviewed and approved a of interest should be declared and the medical writing – they are usually referring manuscript prior to pub lishing. They may involvement of a medical writer should be to documents in the public domain such as have requested additional outputs to be acknowledged. Given that drug develop - journal articles or maybe congress abstracts. generated or suggested that certain ment takes place in a competitive The primary purpose of such publications conclusions are toned down or changed. environment and that the temptation to is to communicate the results of the study They should also have had access to the present results in a favourable light is to the scientific community and wider data to verify the presentation of the results strong, the aim of the above is to prevent world. The investigators who appear as and the conclusions. But large volumes of ghost-written articles. In the past, such authors of an article about a clinical trial outputs are generated and in the real world articles have used the veneer of peer- should rightly take responsibility for the where investigators are busy clinicians, only reviewed respectability for marketing ends. content. Thus, all authors should have been the most diligent will have gone through Greater awareness of these issues,
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 59 combined with stringent public disclosure have been followed should reflect a ially confirms that to the best of his or her requirements, giving readers access to the consensual company position. knowledge, the trial was conducted accord- results pertaining to the main efficacy The target audience, the health authority ing to Good Clinical Practice and that the endpoints and safety, have no doubt reviewers, is aware of the conflict of interest results presented reflect those obtained. reduced the extent of these dubious (the company will ultimately want to see the Unlike the author of a publication, the practices, though there is always room for drug approved) and so the documents will investigator doesn´t necessarily have to fully improvement. generally be read with a critical eye. Audits agree with the interpretation of the results can ensure the accuracy of the data and to sign the investigator signature page, just Realities of clinical research health auth orities have the option of asking acknowledge that the study was app rop - Although the investigators named as authors further questions in many types of inter - riately conducted and that the results take public responsibility for the article actions. If it transpires that the company has themselves are accurate. In any case, detailed content, there is a tacit recognition (perhaps attempted to mislead the health authorities, interpretation of the results is not usually not always addressed in discussions about the consequences both financially and in included in the discus sion section of a CSR. journal authorship) that the study design terms of loss of faith and credibility can be Although decisions about which results are and analysis is largely done by the drug severe. From my experience, companies take highlighted and how they are presented in company. So although the investigators will their interactions with the health authorities the text of the CSR may influence the have been the ones who actually administ - very seriously and “we can´t be seen to be readers´ perception of the study, the most ered the study drug to the patients, in terms hiding anything” is a common sentiment in important outputs are appended to the of the big picture, a team within the discussions about data presentation to the document and will be available to reviewers. company, involving many employees with health authorities. Certainly (and again I am Thus, CSRs are essentially factual docu - expertise in many different areas (bio - speaking about my personal impression), ments with limited opportunity for spin. statistics, clinical science, clinical pharm - companies nowadays show plenty of Higher level documents do of course acology, and so on) will have been resp- apprehensive respect to the regulators who include company interpretation of the data. onsible for study design and administrative can make life very difficult for a company. The clinical overview, for example, may aim aspects. The company will have drafted the to convince the regulators that the comp - protocol (although investigators may have Investigator conformity in any´s product should be approved. The provided input to study design through regulatory documents regulators, for their part, have extensive participation in steering committees and Although most regulatory documents are access to supporting data and can make up advisory boards). Likewise, the statistical authored and approved internally, a comp - their own minds. Indeed, the Food and Drug outputs will be produced within the any must sometimes seek the signature or Administration takes a bottom-up approach, company, and drafting the clinical study approval of someone external to the paying relatively little attention to the higher report (and public disclosure of the results company. For example, as per International level documents anyway and performing on a clinical trial registry if appropriate) will Conference on Harmonisation (ICH) their own analyses of the raw data. also be the responsibility of the company. guidance, clinical study reports (CSRs) must be accompanied by the signature of the Journal articles and regulatory Authorship of regulatory documents principle investigator (for a single-centre documents – two different worlds Unlike journal articles, regulatory docu - trial) or the coordinating investigator (in the In short, clinical development is a complex, ments are generally prepared for submission case of multicentre trials). The regulations collaborative process involving many comp - to the health authorities and are not available are rather vague as to who should be any employees, hired external workers, and in the public domain (although this may be designated the coordinating investigator. For of course the investigators and other medical changing with the current shift towards example, ICH E3 states that the figure of the staff. Journal articles describing an inter vent- greater transparency). Companies will have coordinating investigator will usually be ional trial generally aim to disseminate the well defined Standard Operating Procedures designated by the protocol. However, the results. The limited number of authors who that describe exactly who is responsible for wording does not make this obligatory and, take public responsibility for the article reviewing and/or approving a document or in practice, the protocol is often silent on content may not accurately reflect the extent sections of a document. The medical writer this matter. If the study has a Data Safety of the effort or the real intellectual input. assigned to the project is not an intellectual Monitoring Board (DSMB) or some other Regulatory documents, in contrast, if author in the sense that authors of journal study oversight body, then one common authored and reviewed according to comp - articles are (or should be), but rather has a practice is for the DSMB chair to be made any guidelines, with input from the relevant more technical role. The responsibility of the coordinating investigator. Another approach departments, should provide an accurate and medical writer is mainly to compile and might be to ask the investigator who has detailed description of the clinical develop - present data from a wide range of sources recruited most patients. Either way, the final ment process and represent the company and ensure that regulatory documentation decision often has a political dimension. For position. The role of the regul at ory medical requirements are met. As a result, there is example, if a publication is planned from the writer is a technical one, and there is usually usually no need to name a medical writer as results of the study, then the lead author and no need to acknowledge his or her input. an author, or explicitly acknowledge his or the coordinating investigator may be one her participation in the document, which if and the same. the appropriate review and approval cycles The investigator signature page essent - Gregory Morley
60 | March 2016 Medical Writing | Volume 25 Number 1 English Grammar and Syntax
SECTION EDITORS Good Writing Practice ✒ Wendy Kingdom ● [email protected] Writing abstracts for congresses (2) ✒ Alistair Reeves ● [email protected] Tables and Figures overload a table with data if the end product Unlike manuscript abstracts, congress is illegible in the abstract book? To ensure abstracts may often include tables or figures, that tables and figures are published clearly, erroneously translated table and whether or both. Many congresses allow these to be check the minimum resolution and size supplying it as a figure would be preferable. submitted alongside the abstract text, and requirements for the congress. Many When supplying tables as a figure, a this is often the most concise and clear way congresses provide little guidance here; if the number of additional details must be to present large amounts of data. congress abstract book will be printed, aim considered. Special care should be taken for the standard print resolution of 300 dpi. when using superscript footnotes. In our Limitations of tables and figures experience, these are sometimes not pub lish - Including a table or figure may reduce the Tables ed clearly in the congress book, whereas available character or word count of the If supplying tables in table format (as using square brackets for footnotes prints abstract. Consult the congress abstract opposed to uploading as a figure), these will well (ie. [a] instead of a). Avoid over-com - guidelines to see if this is the case; some usually be transcribed and copyedited by the partmentalising data with grids and excessive congresses count each table or figure as congress in the abstract book. While this row and column borders. Tables should be equivalent to 250 characters of body text. If may seem the preferred option for tables, simple and clean; lines and shading should be more than one table or figure is to be this may introduce errors, which may thoughtful and should aid in the comp re - included, one way to reduce the impact of disturb the message and clarity of complex hension of the data presented (Figure 1). this on the overall word count is to upload a tables. Incorrect, or non-translation of row single multipanel image containing a indenting can make the table harder to Figures number of tables or figures. Depending on follow, as can failure to embolden important Many congresses have no specific rules the congress and stipulated file size limits, category headings. When the contents of an against supplying coloured figures. Colour this may count as one figure overall. All table individual cell contain a lot of data, these may be inherent to the figure, eg. photo- and figure titles and footnotes should be will invariably spill onto two rows and the graphic material or imaging scans. Otherwise, included in the image file to save additional most appropriate position for the line break if colour will improve the under standing of characters or words. may not be used. Using additional columns the figure (graphs and charts), its use should Unlike manuscripts, there is no opport - can also resolve this problem; for example, be encouraged. When developing figures in unity to see proofs of congress abstracts, instead of including the value and upper and colour, consider colourblind users by therefore it is crucial to ensure that any tables lower confidence intervals in the same avoiding red-green and blue-yellow contrasts. or figures will be clear and readable when column, add a separate column for the Graphs and charts should clearly focus published in the final abstract book. Why intervals. Consider the risk of an on the data. Figures may be resized and loss in quality may occur. Gridlines should Including the title generally be avoided: include only major in the image will Restrict the use lines in a narrow width and lighter shade. conserve of horizontal characters borders Consistency is key in figures. Consistent shading must be used for each data series and text sizes should be aligned for axes Explanatory rows titles, data labels and other on-figure text spanning entire table width may (keeping in mind the final size of the figure be helpful in the abstract book). Inconsistency is more Use shading carefully to noticeable than consistency, therefore a enhance data well-presented figure will draw attention to protection the data in part by not drawing attention to in-line footnotes appear clearer other less important aspects of the figure. than superscript Sana Eljamel Costello Medical Consulting, Cambridge, UK Figure 1. Example of a well-presented congress abstract table [email protected]
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 61 Medical SECTION EDITOR ●✒ Lisa Chamberlain James Communications [email protected]
Editorial producing well-written documents. Adam is statistical reviewer. As we all know, so now in the role of statistician, but having much time and energy can be wasted in Dear all, been an accomplished medical writer poor review cycles, with non-specialists A very warm welcome to the first issue of himself, he is perfectly placed to give us offering their ‘wisdom’ on sections outside Medical Writing in 2016! some excellent insights into the review of their remit, and it’s in everyone’s interest This issue is dedicated to authors and process from the reviewer’s side as well as to make review cycles as efficient and authorship, so I’m delighted to have an from the writer’s side. useful as possible. article for this section from one of Adam’s thoughts and tips are particularly As for whether Adam is now a ‘poacher EMWA’s authorities on all things author- useful for anyone sending out their first turned gamekeeper’ or a ‘gamekeeper ing and ghost writing – Adam Jacobs. document for review, but I think even ‘old turned poacher’ – I’ll leave that for you all In this issue Adam discusses the roles of hands’ can learn something from his to decide!! Bestest. reviewers in the collaborative process of experiences as a reviewer – particularly as a Lisa
Poacher turned gamekeeper
Medical writing is a collaborative process. about it. Whether the writing is for a study audience, the collaborative process is Medical writers seldom write about their report for regulatory purposes, a peer- broadly similar. The medical writer must own research. Typically other people do the reviewed journal article, a conference collaborate with researchers to make sure research, and the medical writer writes abstract, or something intended for a lay that the end product accurately describes
62 | March 2016 Medical Writing | Volume 25 Number 1 the research, is suitable for the target way that makes perfect sense, then I will not observed, then that’s a job for the medic audience, and is clearly written. change it, even if I would have written it more than it is for me. I have been fortunate enough to have differently. That’s not my job. It’s the It is also helpful if I know whereabouts experienced this process from both sides. I medical writer’s job to decide how to phrase the document is in its quality control used to be a medical writer, and I am now a things. Maybe there was a good reason for process. If I see a typo or misplaced comma statistician: one of the researchers with writing it that way that I wasn’t aware of, in the first draft of a document that I know whom medical writers need to collaborate. such as complying with a client’s style guide. is going to have a couple of rounds of editing I’m not entirely sure if that makes me a Maybe my idea of how it should be phrased and proofreading before it sees the light of “poacher turned gamekeeper” or a is a bit odd and the medical writer’s version day, then I’m not going to waste everyone’s “gamekeeper turned poacher”. Make your is clearer anyway. And even if my way of time by telling you about it. If the document own mind up about that. writing it is better, then so what? No drug is supposedly a final version, then perhaps it But either way, I think my experience of ever got rejected by the FDA because they would be more helpful to point out things medical writing was fantastically useful in didn’t like the way a sentence was phrased in like that. helping me to make sure that my a study report. Often medical writers will have questions collaboration with medical writers is as What I do focus on is the sort of thing for me in a draft document, often inserted as efficient as possible. Having been a medical that was the reason why the medical writer comments. That’s great. If there are specific writer myself, I know what kinds of wanted a statistician to review the document things you need to know from your contributions medical writers find helpful in the first place. So, for example, does the statistician reviewer, then ask me. And it’s and what kind of things piss them off. statistical methods section accurately helpful if the questions can be made as Probably top of the list of things that piss describe the analyses that we actually did? specific as possible. “What do you think of Have statistical results described in the this?” is less helpful than “Is my results section been properly interpreted? interpretation of the relevance of the upper Do the conclusions as written by the limit of the 95% confidence interval correct medical writer follow from the results? here?” If you are not sure what to write There can, of course, be a fine line about something and need some help, then between commenting on what is written please be clear about whether you need me and how things are written. Some statistical to explain to you what’s going on so that you concepts do require a certain amount of can write something appropriate or whether precision in the way they are expressed. I you want me to supply a ready made will comment on the way a sentence is paragraph of text. written if I feel it is missing some statistical Adam Smith, the influential 18th century subtlety. For example, if a medical writer Scottish economist, explained at some were to write (and I’m sure no EMWA length the benefits of division of labour. He members would ever do this!) that described the example of pin making, in treatment A was superior to treatment B which some workers drew out the wire, when in fact we have just done a non- others cut it, others sharpened the point, inferiority analysis that only shows that and so on, and how this was more efficient treatment A is not inferior to treatment B, than single workers making entire pins by then I would correct them. And if text is themselves, as it allowed for specialisation. unclear or misleading, then I will comment So it is in writing about clinical research. on that as well. Statisticians have expertise in statistics, So what can medical writers do to help medics have expertise in medicine, and their reviewers be efficient in their reviews? medical writers have expertise in First, I think it is always helpful if a medical communication. If we all stick to our own writer tells me which parts of a document I areas of expertise and recognise the need to review, or, if I am expected to read expertise of others, then we will find that the whole thing, then at least which parts I research is written up more efficiently. should pay particular attention to. If someone sends me a 150 page clinical study Disclaimer report to review, it is not a good use of time This article represents my own personal for me to review the whole document in views and does not necessarily represent the great detail. It is far better that the clinical views of Premier Research. project manager spends time looking in detail at what was written in the visit medical writers off is gratuitous nitpicking. schedule part of the methods section than It is not only annoying, it is a waste of that I do. And if the adverse events section Adam Jacobs everyone’s time. So if I come across a contains substantial discussion of the Senior Principal Statistician, Premier sentence that the medical writer wrote one clinical relevance of the adverse events Research Ltd. Twitter: @statsguyuk
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 63 Lingua Franca and Beyond
Authors and co-authors SECTION EDITOR yielded 427 hits), many of them published in such prestigious journals as The Lancet, This issue of Medical Writing is about ✒ Maria Koltowska-Häggström the New England Journal of Medicine and Authors and Authorship, a topic, which – ● maria.koltowska-haggstrom@ the British Medical Journal. He was also a despite stringent rules and regulations – is propermedicalwriting.com co-editor of the first edition of the Oxford sensitive, culturally-dependent and often Textbook of Endocrinology. Professor Shalet full of emotion. I guess that we could have to explain what the rules are and why we do writes not only scientific papers but also endless discussions as to why papers from not meet the authorship criteria. This, Hotspur’s stories, many of which were some regions have close to 20 co-authors, however, is not what I would like to address published in The Endocrinologist. But now while those from other regions are authored in this issue of Lingua Franca and Beyond, Steve describes for us his early lesson on by just a few researchers. We could also, for although if you would like to tell us about how to select co-authors. This lesson hours, share different strategies on how to your own authorship-related experience, resulted in the formulation of his own handle heads of departments who hardly how you manage such situations and what guidelines for future collaborations. Is it know the title of a paper yet insist on being your approach is, you are more than something to be shared with your co- if not the first author then at least the last, welcome. We will publish it in one of the authors or perhaps you can use his advice to senior author. I am sure that a glass (or two) forthcoming Medical Writing issues. establish a trustful relationship with your of wine would make our discussions even In this issue of Lingua Franca and Beyond, clients? ☺ more vivid and creative. I would like to introduce Professor Stephen Have fun reading it! We, medical writers, frequently witness M Shalet from Manchester in the UK. He is situations that fall far from the ICMJE one of the leading endocrinologists in the guidelines and put us in a rather uncom - world and an author of numerous articles fortable position. We also quite often have (PubMed search of 23 November 2015 Maria Kołtowska-Häggström
Choosing a Collaborator complimentary remarks and the article was These guidelines have been as follows: if you duly accepted without any fuss. The only do not want unfair competition, never work The project looked a promising one. We slightly unusual aspect was the request by with anyone with a double-barrelled name, planned to determine, using a rat model, if the journal for the first names of all authors. or with the second, third or fourth or even chemotherapy-induced damage to an Previously, I had only published in journals junior placed after their name. In fact never endocrine gland could be modified by that used authors’ surnames and initials but work with anyone with a first name that endocrine manipulation induced before and I could not see any problem with the contains more than five letters! during the period of time that chemo - additional use of first names. The proofs When you come to consider collabor - therapy was given. We had an excellent team were sent to the senior scientist for checking ative research and are thinking about and everyone was making a significant and, therefore, I was not aware of the possible collaborators, do not worry about contribution; there were four of us, Gerry, disaster about to unfold until the article intellect, motivation, capacity to see a Ian, me (Steve) and Barry. From a personal actually appeared in print. This article was project through to completion, writing skills perspective, this was my first real attempt to going to be the big one, big enough to make or even the grandeur of their CV. Just be involved in research studies, which tested my reputation! After months of waiting I sat demand to see their birth certificate! a hypothesis as opposed to more clinically at my desk and scanned the title page, and Whatever the various contributions of orientated observational studies. I felt that authorship: Gerry – Ian – Steve – and different authors, a ‘Steve’ will never be potentially it represented a genuine step Barrington – Barrington! I was scarcely able noticed in the close vicinity of a ‘Sebastian forward in my research profile and to take in the full horror of what lay in front Montmorency’ or a ‘Montague Kingsley the subsequently my hopes were raised further of me. Barrington, what a name – everyone fourth, junior’. The only alternative, apart by the fact that within less than 2 years the called him Barry. Why, oh why, did he have from giving up, is a name change, which results of the study supported the initial to be called Barrington? I knew immediately provides you with an unforgettable moniker, hypothesis. Thus, it was time to publish our my chance of glory had gone. Who on earth but that is really risky and lays you open to findings and, as a mere clinician involved in is going to pay any attention to a Steve, when the possibility that the majority of potential basic science experimentation for the first there is a Barrington on the team sheet? collaborators will not choose to work with time, I chose to rely on the experience of my It was in the wee hours of the morning you! senior colleague from the medical school. following the discovery of my collaborator’s He chose an American journal with a high real name that I formulated certain absolute Stephen Shalet impact factor, the referees made resolutions regarding future collaborations. [email protected]
64 | March 2016 Medical Writing | Volume 25 Number 1 Gained in Translation SECTION EDITOR ✒ Laura C Collada Ali ● [email protected]
Editorial in context and transfer it within the target doctor (MD) or a linguist. language constraints, i.e., accurately (all With this article, we hope to shed some Welcome to the Translation Section meaning has been transferred), precisely (all light on this and to demystify some clichés. editorial! nuances of the language, tone, intent, style Enjoy the article! Who is qualified to author a medical have been preserved in the target language), translation? This is one of those topics that correctly (grammar, syntax, orthography References we often read about on professional rules have been observed), completely (no 1. Txabarriaga R. January 2009. translation forums and discussion groups. It part of the original was omitted and nothing IMIA Guide on Medical Translation. is, indeed, a never ending discussion. On the has been added to the target text), and Retrieved from: IMIA Guide on Medical Translation, Rocío consistently (specific terms, stylistic http://www.imiaweb.org/uploads/ Txabarriaga says: “The real indicators of elements and language-specific norms have pages/438.pdf proficiency in translation are knowledge of been consistently used throughout).”1 Yet, the subject matter, knowledge of relevant the discussion which has gone on for so long terminology, the ability to discern meaning is about who does a better job, a medical Laura C Collada Ali
Authoring medical translations – to MD or not MD?
Of all the translation specialisations, medical translation is one which constantly attracts an enormous amount of interest. Trans - lation forums are full of posts from translators asking how to get started in this field: at the same time, it is also considered – fairly universally – as one of the most difficult areas to translate successfully, for a variety of reasons. Due to the particular nature of medical translation, and the difficulties associated with it, the debate on who makes the better medical translator – a physician trained in languages, or a translator trained in medicine – is one which has been raging for many years. And it shows no signs of abating. This debate is sparked by many factors – the increasing “access - ibility” of translation as a profession, the bewildering number of qualifications and accreditations available, and the increasing regulation of the healthcare profession. The purpose of this article is two-fold. Based on a survey we conducted through professional associations, discussion groups and social media, and the 332 responses type of work, how established professionals their experience and background: received, we hope to shed some light on entered the profession and gained exper - 1. Are you a specialised medical translator? what makes a translator truly “qualified” to ience, and what medical translators consider 2. Are you a medical doctor who has succeed in the medical field. And in doing to be the necessary traits for a “good” become a translator or a translator who so, we hope to demystify some of the aspects medical translator. has specialised in medicine? of the profession that aspiring medical 3. Which of these two professional translators may be curious about, such as the One survey, eight questions figures do you feel is best qualified to particular difficulties associated with this The survey asked medical translators about work as a medical translator? An MD,
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 65 a translator, or other. As the overwhelming majority of respond - • 34% medical doctor or other science or 4. If a translator, how have you specialised ents (73%) show, medical translators health professional who has become a in medicine? normally work full-time in the field; just translator 5. Do you work full-time or part-time? under 20% were part-time (Table 2). Some • 59% translator who has specialised in 6. How many years of experience in the were full-time freelancers who engaged in medicine field do you have? other medical writing activities, others trans - • 6% other 7. What kind of texts do you feel lated part-time while doing other healthcare comfortable translating? activities such as interpreting, work as Which background makes a 8. What do you consider to be the partic - doctors, or other healthcare professionals. better medical translator? ular difficulties related to medical So who did respondents feel was “best translation? qualified” to undertake medical translation? One obvious limitation of the survey is that > 5 years On the surface, it seems to be the eternal it was self-reported, and some discrepancies dilemma: as one respondent remarked, “the show that the actual number of “specialised < 5 years doctor knows the subject matter, but may medical translators” could be higher or not have the linguistic skills. The translator lower than the result shown. That said, the Other has the linguistic skills, but lacks the survey was directed at those working in 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% knowledge the doctor has acquired during medical translation, therefore it is probably their training and practice.” If we delve a safe to assume that this number is Table 2: Q6 – How many years of little deeper, however, some interesting reasonably accurate. experience in the field do you have? insights emerge.
The identikit of a medical translator The vast majority of respondents had over MD> So what are the overall characteristics of five years hands-on experience in the field Translation medical translators? According to Andriesen1, (73%) and many specified that they had Translator> six out of seven translators are women, and been in the field much longer, with medicine their background “is most often in the study responses ranging from ten to fifty-five years of languages or translation, but quite a few of experience (Table 3): these figures agree Other
(approximately 20%) have a medical back - with Andriesen’s observation that “good 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% ground.” According to our survey, the vast medical translators have many years of majority of respondents [86%] iden tified experience and are usually involved in Table 5: Q3 – Which of these two themselves as specialised medical translators medical translation most or all of their professional figures do you feel is best – the 9% who checked “other” [29 resp - time.”1 qualified to work as a medical translator? ondents] included a teacher of medical translation, who lists medical translation as Half of respondents (50%) checked “other”. one of their areas of expertise: another MD > Of those who chose option A or B, resp - Translation whose medical and medical-related trans - ondents were divided almost equally, just Translator lations ran into the hundreds) (Table 1). > Medicine slightly in favour of translators specialising in medicine, with 26%, versus 23% Other favouring MDs specialising in translation
Yes 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% (Table 5).
No Table 4: Q2 – Are you a medical doctor “An MD or other health professional is who has become a translator or a translator more qualified.” Other who has specialised in medicine? A number of respondents felt MDs or other
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% health professionals were more suited to the Respondents were not only MDs or task of medical translation. In general, such Table 1: Q1 – Are you a specialised translation-based professionals, but also participants felt that medical translation medical translator? nurses, biologists, veterinarians, chemists, requires a body of knowledge that pharmacists, and many other scientific translators who have specialised in medicine Full time professionals. (Table 4). Of the 90 “other” do not – or cannot – have. Some felt that the responses shown in Table 2, only 22 had no sheer breadth of the medical field meant that Part time medical or scientific background what - translators specialising in medicine would soever. If we add these other scientific take a long time to achieve the necessary other professions – including, as declared by the proficiency, and that CPD alone would be
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% respondents, biologist, nurse, veterinary unable to give the same level of expertise, surgeon, biochemist, physicist and others – except in rare cases. Another recurring Table 2: Q5 – Do you work full-time to the (A) category, the numbers look a little opinion was that a translator specialising in or part-time? different: medicine does not have the background to
66 | March 2016 Medical Writing | Volume 25 Number 1 know what is correct or not, or to essential attribute voiced by many was the The “other” text types declared by resp - understand the complexity of medical texts, ability and willingness to continuously learn ondents were many, however the overriding or is simply unaware of the gaps in their more – indeed a strong theme underpinning sentiment expressed by participants was that knowledge, making them more prone to the entire survey was the need to continue they would only take on texts they were errors. studying and to acquire the knowledge that comfortable with and capable of concluding is lacking. “Both start with key knowledge”, successfully. “A translator specialising in medicine one participant noted, “but also have much is preferable” to learn.” What makes medical Other respondents felt a translator specialis- translation different from ing in medicine was more desirable for a What kind of texts were participants other types of translation? number of reasons. The sensitivity needed comfortable with? to adapt the text to the target audience and Table 6 shows the number of respondents Shortcomings or ambiguities in the a consideration of its overall compre - who expressed their comfort at translating source text and use of non-standard hensiveness and readability was felt by some the various text types in the medical field. abbreviations and acronyms were the two to be lacking in many linguistic medics: one most serious problems, cited by 61% and respondent felt that translators are much 59% of respondents respectively. Regularatory more keen to learn about medical topics documents Identical acronyms with various than MDs are to learn about language and meanings was another problem, cited by Medical its use, and many felt that it was easier to Communications 48% of respondents (e.g. “aha”> acquired acquire specialist knowledge than it was to Scientific haemolytic anemia or autoimmune gain the translation and linguistic skills articles haemolytic anemia; “ist” > insulin shock User necessary to produce an effective target manuals therapy or insulin stress test; “and” > axillary document, prompting one participant to node dissection or the conjunction meaning note: “we can all study and acquire Other in addition to2). knowledge in specific fields… a translator is 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Other related problems mentioned by bound to have a set of skills (grasp of respondents were poor handwriting, as grammar, style, syntax) that an MD does not Table 6: Q7 – What kind of texts do well as complex language and unclear necessarily have”. Another said: “I have you feel comfortable translating? writing styles, by doctors and medical worked with many doctors over the years; writers alike. Others observed that the their technical terminology is correct, but The fact that respondents were less at ease authoring of texts by non-native speakers they often lack a strong command of the with regulatory documents and user manuals, often made them difficult to understand, target language”. Another opinion voiced by compared to medical communications and and that poor quality control processes many is that being a physician is useful but scientific translations, may be due to the fact often led to errors. These factors conflict not absolutely necessary, since it is that the former two categories require a with the “distinctive features of scientific impossible to translate all fields of medicine, knowledge of the particular restrictions language”, as observed by Lucia Ruiz and that no MD has sufficient knowledge governing these text types (such as EMA Rosendo3, who describes these as “universal across all medical specialities. templates), or the fact that user manuals nature, accuracy, objectivity, lack of often require technical as well as medical expressiveness and emotion, clearly defined “Both can do an excellent job” and scientific knowledge. meaning and connotation in order to avoid Many were of the opinion that both categories could perform equally well, and that excellent results could be achieved by Non Standard Language translators in both groups, provided they Identical acronyms have acquired the necessary knowledge and skills in both areas to do a good job: they Shortcomings or ambiguities were simply seen as two different paths to Collacations arrive at the same goal. Of course there is also the other side of the coin: various Vastness of the field participants expressed opinions such as Extensive research “both figures can be excellent, or very poor medical translators”, and that they had seen Speed of developments good and bad in both groups. The criteria Technical complexity seen as fundamental for a good medical translator were relevant experience in the Other subject matter and appropriate research 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% skills: “whichever category a translator belongs to”, one respondent remarked, “they will always need to do research”. Another Table 7: Q8 – What do you consider to be the particular difficulties related to medical translation?
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 67 any kind of confusion and allow universal certain languages, as well as a lack of medical records and their terminology, communication, lexical monosemic, educational programmes or courses. proved to be an invaluable training ground. appropriateness and correction, and clarity and precision.” How do medical translators The “Accidental” Specialist Other language-related issues raised by specialise? The overwhelming majority (75%) participants were the use of “anglicised So how do translators specialise in reported specialising in medicine through Latin”, or “two levels” in certain languages medicine? The following table shows the experience, although this took different such as English, with the existence of an responses from the participants in our forms. One aspect of specialisation that erudite Greco-Latin term and a more survey. many translators will be able to relate to is popular name, which is more commonly that “you do not choose your specialisation used, such as coagulation (erudite) and – it chooses you”, in the sense that at a clotting (popular), or myopia (erudite) and Through certain point in their careers, translators are experience shortsightedness (popular)3,4 – one particip- offered work in a certain field, and slowly In-field ant notes that “this is not always evident and workshops build up experience this way. One requires careful evaluation”. False friends University participant reported doing their final and new terms without translations or training internship in a medical translation agency, equivalents in the foreign language (related Other and being hired at the end; another began to the speed at which the medical field is doing veterinary translations part-time evolving) were also mentioned, while 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% before starting to do medical translations, collocations, some of which are described and deciding to concentrate full-time on by Peter Newmark5 as being “among some Table 8: Q4 – How have you these, while another contract law specialist of the translator’s biggest pitfalls”, were not specialised in medicine? began translating contracts for clinical trials, seen as particularly problematic, cited by continuing their CPD via courses in other just 15% of participants in the survey. What is the “best” way to specialise? branches of medicine. The “vastness” of the medical trans - American anthropologist and folklorist lation field was the next most-cited Ruth Fulton Benedict famously wrote: “The Personal interest, research and self-study problem (by 55% of respondents, followed trouble with life isn’t that there is no answer, Another strong theme running throughout by the need for extensive research (46%), it’s that there are so many answers”. And the entire survey was a love of the subject technical complexity (41%) and the perhaps we could apply the same sentiment matter. One respondent in particular recalls speed of new developments in medicine here – the striking feature of the information reading medical and scientific books as a and technology (22%). While obviously provided by respondents in their comments child, and drawing anatomical figures in her seen as a major issue for many (almost one was just how many different backgrounds teenage years; this may be an atypical in two respondents), others saw term in - medical translators have: indeed there seem experience, however many respondents ological and other research as positive, a to be almost as many roads into medical have gained experience through their own form of continuing professional develop - translation as translators themselves. research and self study, both in the form of ment that keeps translators up to date, a way the more traditional books and journals, as of learning new techniques, methods and Formal medical education well as the more interactive and modern terminology. One participant noted: “A Perhaps the most obvious, but by no means resources now available, such as specialised translator needs to learn how to the most common. The fact that we limited conferences, workshops, webinars and learn – how to locate accurate, reliable formal medical education to that of doctors MOOC courses, such as those run by information and get up to speed with a when writing the questionnaire, meant that Coursera. While four or perhaps five particular specialised topic quickly. It’s the many of the respondents, as shown in the respondents reported having undertaken translator’s job to read and understand comments to the previous questions, come formal medical translation courses, this was background material well, no matter how from a variety of medical backgrounds, by no means a typical experience. complex.” Of course a medical translator including nursing, veterinary medicine, always has the possibility – indeed the pharmacy, biomedicine and life sciences. Family members and professional ethical obligation, it might be said – to Some have been, or are currently, involved contacts decline a text they do not feel proficient to in medical and clinical research: other Some respondents reported having one or handle. Hence the “vastness” is not seen as medicine or science-related professions and more family members who work in the a problem by some, since translators should backgrounds include lab technician, medical medical sector and who can be called upon simply decline a text they are not able to secretary or transcriptionist, experience in for help and advice, others report close translate. the medical devices industry, medical billing cooperation, consultation and discussion Other points not covered by the survey and insurance, and regulatory affairs. with health professionals and medical options included the regulatory standards Voluntary work was also mentioned, with experts as being an invaluable source of help governing certain types of translations, and some respondents working as hospital and a way to increase their knowledge and the fact that many translators (from both interpreters and translators; others found experience, or to polish their translations. groups) are unaware of these regulations. that their experience in administrative Another reported proofreading of their Others lamented a lack of documentation in positions, and the access this provided to work by senior proofreaders as having been
68 | March 2016 Medical Writing | Volume 25 Number 1 very helpful, as were reference materials here too. The difficulties listed were not References provided by clients. While not all of us are considered such by many respondents, but 1. Andriesen, S (2006) Medical lucky enough to have doctors in the family, rather as a natural part of the medical Translation: What Is It, and What Can the plethora of online help sources, such as translation process: the very factors which The Medical Writer Do to Improve Its the Proz.com KudoZ feature and online drive, stimulate and challenge them. And as Quality? AMWA Journal, Vol. 21, no. 4, glossaries – provided these are used one participant pointed out: while these 2006, pp 157-159. critically and wisely – are available to challenges exist, there is always someone to 2. Jules J. Berman (2004) Pathology everyone. call on for clarification. Some expressed the Abbreviated: A Long Review of Short view that these challenges were no more Terms. Archives of Pathology & The traits of a successful extreme than in other very specialised fields Laboratory Medicine: March 2004, Vol. medical translator (a view shared by Newmark who writes “this 128, No. 3, pp. 347-352. Available on: Given that the purpose of any translation is form of translation may be no more http://www.archivesofpathology.org/ to convey a message, the skill that emerges challenging than that of poetry”), while one doi/10.1043/1543- – almost unanimously – from our survey as respondent felt that medical translation is 2165(2004)128%3C347:PAALRO%3 essential, is the ability to write well. actually easier than other fields, noting that E2.0.CO;2?url_ver=Z39.88- Fischbach6 writes: “Good translating is the better conditions in terms of factors such as 2003&rfr_id=ori%3Arid%3Acrossref. rewriting in the foreign language of the ideas source text quality, deadlines and support org&rfr_dat=cr_pub%3Dpubmed& contained in the original. Indeed, we might actually made this one of the easier areas of Accessed on 20/11/2015. say that a good translator ought to be as translation to work in. One current running 3. Lucía Ruiz Rosendo (2008). English good a writer as the one who wrote the through our body of data was a call for and Spanish Medical Languages: original.” One respondent wrote: “The key teamwork, proposing the combination of a A Comparative Study from a translation to being a good translator in any field is a qualified MD and a qualified translator as point of view. TRANS 2008: 12, pp desire to create a target text with the reader being the ideal solution, a “medical- 231-246 in mind. The translator must be interested linguistic tandem” so to speak, collaborating 4. Van Hoof, H. (1999). Manual práctico in both the subject matter and the language and revising each others’ work. “I think both de traducción médica. Diccionario used.” Understanding and knowing how to of them are qualified to work as medical básico de términos médicos (inglés- translate the terminology in the native translators”, one participant wrote, “BUT francés-español). Granada: Comares. language was seen to go hand-in-hand with when they work together.” Sarai Pahla again: 5. Newmark, P (1979) A layman’s view of the need to a good writer, to be able to “So let’s spend less time comparing and medical translation. British Medical convey ideas simply and directly. Other more time collaborating – if you’re a medical Journal. December 1 ; 2(6202): traits seen as necessary for medical linguist, find a doctor who has studied pp 1405-1407. translators included patience, curiosity, languages and get them on your side... and 6. Fischbach, H (1962) Problems of attention to detail and an ability and a desire if you’re a doctor who has figured out how Medical Translation. Bulletin of the to learn, together with humility and the to work your way through this jungle of an Medical Library Association. July 1962; willingness to check (and double-check!) industry, make friends with the right Vol. 50, No. 3, pp 462–472. facts, not taking for granted that “they know linguists and help each other out! ”2. 7. Pahla S. Medical Linguists vs Linguistic better”. In her excellent blog post, Dr Sarai And one nurse said something Medics. Loving Language Blog. Pahla urges medical translators to “be particularly apposite: “Medical translation Available on: humble enough to admit that we are all must be open to all who either have http://polyglotaholic.blogspot.it/2014 human and all err...” experience or are willing to learn. Why /01/medical-linguists-vs-linguistic- confine this huge field to a relatively small medics.html Accessed on: 15/11/2015. Conclusions group of people?” 8. Van Hoof, H. (1999). Manual práctico To MD or not MD? At the end of this de traducción médica. Diccionario article, there is still no clear consensus, but Acknowledgements básico de términos médicos (inglés- plenty of points for reflection. What does We thank all the professional translation francés-español). Granada: Comares. emerge – and what makes this profession so associations who helped us by distributing unique – is that translators are individuals, the survey to fellow translators and to all the each bringing with them their own colleagues who kindly took time to answer particular experience and know-how. While and comment on the questionnaire. this may sound trite, it is crucial when considering the question in hand. Translation proficiency, indeed, is not merely a result of training, but of many other factors, evident in the wide number of Fiona Peterson routes taken by medical translators to arrive [email protected] where they are now. We have seen that medical translation has its own set of Laura C Collada Ali challenges, but participants were divided [email protected]
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 69 Medical writing teaching
A novice’s experiment with a wiki on a writing course
A wiki? What is that? manuscripts. This calls for an understanding • explain the purpose of the wiki exercise The name ‘wiki’ was probably what attracted of the required academic content, and and how it related to the learning me most about using this e-learning tool in format of a scientific journal article as well objectives my teaching. As a New Zealander, I as the ability to present ideas and findings • give some examples of relevant items that associated the word with the Maori terms logically using common reporting standards could be added ‘waaka’ (canoe) and ‘tiki’ (wooden carving) and ethical publishing principles. • describe how to open and add wiki pages, and of course just an odd way of spelling I thought it would be interesting to see if and how to add items and comments ‘kiwi’. I thought that at the very least, I would a collaborative wiki exercise could help the • provide deadlines for adding items and feel some affinity for the wiki, even it proved students to develop a list of items that describe how we would work with the challenging to use. should be checked before a manuscript is wiki during the course. How wrong I was! At least for a good shared with others or submitted for while, before I had experimented with the publication. The aims of the task were to Although the students in the first writing wiki on two writing courses. I am not the strengthen the individual student’s ability to course all added useful items to the wiki, most technologically literate person, but I reflect on the quality and content of their there was little online discussion of each found it more difficult than expected to text and to support them in identifying key other’s items and the students did not delve into the world of e-learning and to elements of scientific manuscripts. appear to actively use the checklist when appear knowledgeable when explaining the reviewing one another’s manuscripts in the wiki task to my students – and to feel Creating a wiki on an final class session. I think the students confident that it would work. e-learning platform hesitated to alter other students’ items A wiki is a series of linked pages on a It took me quite a while to understand how because they did not know each other website, where selected users can write to set up the wiki and give others the before the course and came from different freely and also edit and comment on other opportunity to write in it, and indeed to see scientific backgrounds.1,2 Although most users’ texts (it is the basis of Wikipedia). I how to structure it. The encouragement and students thought the exercise had been used a wiki exercise as part of my lecturer’s technical assistance from the IT consultants useful, and two said they had been inspired training course at the University of Southern for the lecturer’s training course were to create their own wiki checklist, it was also Denmark in Odense. The university has invaluable here! But then it was relatively noted that the wiki checklist was too made e-learning a priority within a frame - easy to set it up in a format that gave the general. I realised that more class time work of “active teaching and learning”, where students a quick overview of the wiki should be spent on the wiki to utilise the students are stimulated to be active in a way structure and the freedom to add new items. students’ varying scientific backgrounds and that generates in-depth learning and I chose to use the wiki homepage to describe writing experiences. motivates both students and lecturers. the purpose of the exercise and then created In the second writing course, I explicitly During our one-year training course, we four new pages for different aspects of a asked the students to use the checklist while were to choose an e-learning tool and manuscript (General layout, Language, preparing their own manuscripts and then develop a project for our students that Content, and Tables and figures). Each the final class session started with the would facilitate their learning. The choice student was to add new items to the pages. students discussing the wiki checklist in range was wide and included not just wikis I was surprised at how much explanation small groups. This resulted in a much more but also podcasts, flipped learning, student- was needed to describe the wiki exercise. lively discussion about the meaning and use response systems, blogs, discussion forums, Most of my students had never used a wiki, of the wiki items and their relevance for etc. so I needed to: different types of scientific manuscripts, I teach academic writing to under - and I think the students took greater graduate students and PhD students, aiming ownership of the product. The written to help them develop their writing skills to SECTION EDITOR feedback from these students showed that produce effective, scientifically sound, and the wiki exercise had been useful in ethical journal articles. One of the learning ✒ Claire Gudex assessing the quality of their own and objectives is that the students can critically ● [email protected] others’ manuscripts, and would be useful assess their own and other people’s for their future manuscripts.
70 | March 2016 Medical Writing | Volume 25 Number 1 Conclusion approach where small groups of students References The wiki exercise helped open my eyes to use an online discussion forum to jointly 1. Carr N. Wikis, knowledge building the potential of e-learning activities. It was develop the wiki checklist, and then have the communities and authentic pedagogies definitely harder than I expected, though. results discussed in class. in pre-service teacher education. In: Not just because of the practicalities in So perhaps my initial thoughts about the Hello! Where are you in the landscape understanding and setting up the exercise, wiki were not so wrong after all. The of educational technology? Melbourne: but also because it requires you to think approach can be tricky to handle effectively Proceedings of the Australasian Society carefully about what you want to achieve (like a canoe) and requires patience (like for Computers in Learning in Tertiary with the activity. I spent much thought on locating the shy, nocturnal kiwi) but after Education, 2008. Available from: how to inspire the students to participate some practice, it can be mastered and used http://www.ascilite.org.au/conferences actively in the exercise and thus benefit from successfully as a learning tool. If others have /melbourne08/procs/carr-n.pdf the collaborative learning. any experience using wikis or other e- 2. Wheeler S, Wheeler D. Using wikis to I think that in the end I succeeded in learning activities to teach (scientific) promote quality learning in teacher encouraging the students to reflect more writing skills, I would very much like to hear training. Learning, media and critically and systematically over their own about it. technology 2009;34(1):1-10. and others’ manuscripts. In future classes though, I might experiment with a different Claire Gudex
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 71 Profile SECTION EDITOR ✒ Beatrix Doerr ● [email protected] An interview with Phil Leventhal Editor-in-Chief of Medical Writing How and why EMWA members should contribute to the journal
At the beginning of this year, Medical any medical writer, irrespective of MEW: What is the process of preparing Writing (MEW) changed from Maney experience level, can publish an article in and submitting a paper, and where can Publishing to Hastings Printing Company. MEW. Your personal experiences will be I find the author’s instructions? This has allowed the journal to dispense relevant to someone, no matter what your with the need for copyright transfer and to experience level. Even if you are PL: The best way to start is to contact the consider open access. The idea of open inexperienced, the information you collect Editorial Assistant ([email protected]) and access was brought up several times, and a as you learn and the process you go propose an idea for an article. Assuming LinkedIn discussion last spring, coupled through as you master new subjects will be that we agree on the overall theme, I will with the pending change in publishers, helpful to someone. You can write about ask the Editorial Assistant to send you the encouraged EMWA to launch a member feature article template and the something you know about or even survey about it. The results of the survey instructions for authors. The feature article something you don’t know yet but want, or led to EMWA’s new policy of open access template is a Microsoft Word file that need, to learn. For example, you might be for feature articles. contains all of the formatting needed to In the light of these changes and asked by your employer or client to prepare the article. The specifics are also considering the theme of this issue prepare a kind of document you know given in the instructions for authors, but (Authors and Authorship), we thought nothing about, and your research about the the template simplifies the process and that we should ask Phil Leventhal, Editor- topic could end up as an article. makes the Editorial Board’s job easier. You in-Chief of MEW, to discuss what authors can download the feature article template need to publish in MEW and why they MEW: So if junior writers can submit and instructions for authors from the should do it. articles, how do you ensure that the journal website (http://journal.emwa.org) Phil has been a medical writer since quality is sufficient? or request them from our Editorial 2003, when he transitioned from Assistant ([email protected]). pharmaceutical research. Phil is originally PL: When we receive an article, I or from the US and has a PhD in Bio - another member of the Editorial Board MEW: A frequent cause of frustration in molecular Chemistry from the University will critically review the content and medical writing is the rejection of an of Wisconsin. In addition to serving as the writing and then work with the author to article. Could you explain how articles Editor-in-Chief of MEW since 2012, he make sure that the quality is sufficient for for MEW are selected? has been an instructor at the Medical publication. This can include several University of Innsbruck and is an Adjunct rounds of revision by the editor and the PL: Most of the time, articles are solicited Associate Professor at New York contributors. We only ask that contributors by me or a member of the Editorial Board, University. Phil has also led workshops on but more and more articles are coming in remain open to having their writing edited medical writing for EMWA and various unsolicited. Except for the rare original and, if necessary, reworked. institutions in Europe since 2011. research article, articles do not go through a formal peer-review process. The decision MEW: Many medical writers may ask MEW: What about non-native speakers to accept the article is up to me and the themselves if their level of experience is who might not be confident about their Editorial Board member assigned to the good enough to submit an article to English? article. Honestly, it’s rare for us to reject an MEW. Who can submit an article? Is article. I think that I have rejected about there a specific level of experience PL: All of our editors have excellent three articles in the last 3 years. Even in the contributors need? English skills, and they are asked to work worst cases, we would rather work with the with the contributors to perfect the contributor to develop an article so that Phil Leventhal (PL): Of course, we love English as part of the standard review and everyone is satisfied with and that will be receiving contributions from experts, but revision process. of practical use to our readers. The rare
72 | March 2016 Medical Writing | Volume 25 Number 1 cases of rejection happen when the subject knowledge about medical We definitely Usually, I ask people is not appropriate for our readers, it is writing. For example, when welcome volunteers – interested in joining our clearly advertising for a company, or the I started at my current there’s always room board to write or to an edit an contributor refuses to make changes we company, I wondered for additional initial article or two so that I consider essential. “What are the most common Associate or can judge their abilities. reasons that articles are Section Editors. Anyone interested in MEW: What other advice can you rejected?” The research I did volunteering for the board provide to authors who would like to answering this question not can simply send me an email. submit an article? only became an article but also added How I became Editor-in-Chief is a to my understanding of the peer-review good illustration of how volunteering for PL: The most important thing to process, which has helped make me a EMWA is an amazing opportunity. Back in remember when writing for MEW is to better publications writer. 2007, I volunteered to write an article think about your target audience – A third benefit of publishing in MEW is called “Freelance or employee: Which is professional medical writers of varying that the article is concrete evidence of your better?” for MEW’s precursor, The Write experience levels. The article should be expertise that can be shared with a Stuff. I really liked this magazine-style of practically useful and include examples, prospective client or employer. As with writing, so I pitched the idea of a regular and it should be written in a professional peer-reviewed articles that you may have column on my specialty, manuscript but conversational tone. We are not published during graduate studies, your writing, which I ended up writing for two looking for a boring, academic style but articles can (or should) be listed on your years. That, in turn, led to my guest editing rather a more dynamic magazine or cv, and thanks to open access, they can be two issues of The Write Stuff and agreeing newsletter style. We strongly encourage distributed freely, either in print or to serve as an Associate Editor. When that you include tables, figures, and pull- electronically. MEW’s first Editor-in-Chief, Elise quotes (key bits of text that appear in large, Langdon-Neuner stepped down in 2011, highlighted text) to help maintain interest MEW: Once I publish in MEW, don’t it was natural for me to take the reins. It’s and emphasise key points. I relinquish the rights to the writing? been challenging but fulfilling, and I am happy to continue during our transition to MEW: Why should I write an article for PL: Since switching to the new printer, a new printer and new format. MEW? contributors no longer have to assign copyright to us or the publisher. MEW: Thank you for taking the time to PL: Writing an article for MEW is an Contributors retain full ownership of the share this important “insider” excellent way to advance your career and material, although if you want to provide information with us. Publishing in to improve your visibility within the or re-use the full article or substantial MEW is obviously a great way for medical writing field. It establishes that portions of it, we ask that you state that it medical writers to advance their careers you are an expert in your area, someone to was originally published in MEW and give and increase their visibility within the turn to when other medical writers have at least the volume, issue, and page medical writing field. questions. This is even the case for junior numbers. writers, and it is especially true now that feature articles will appear on Google and MEW: If someone wants to participate Google Scholar and will be available open more or become a member of the access. Because of open access, you will be Editorial Board, what experience do able to post your articles on any website they need, and who should they and share them with potential employers contact? For that matter, how did you or clients. For companies and freelancers, become Editor-in-Chief? this means improved visibility, so it’s essentially free advertising. PL: We definitely welcome volunteers – Another benefit of writing an article for there’s always room for additional MEW is that it is a great way to learn and Associate or Section Editors. We need add to your professional expertise. Every people with excellent English writing skills time you prepare an article, you will need and an interest in writing and editing to do some research, even if you are already magazine-type articles, something that Phil Leventhal can be contacted at an expert. This will expand your most medical writers don’t get to do. [email protected].
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 73 EMWA News SECTION EDITOR ✒ Beatrix Doerr ● [email protected]
session at the end. Webinars are free for EMWA members. Attendees use the Citrix GoTo Webinar platform. The technology is best-in-class and does not require a phone or complicated installation or permissions. Registration will open at least 2 weeks prior to each webinar and will be announced via LinkedIn, Facebook, and Twitter. Once open for registration, you can register for any webinar simply by following the green “Register here” button found at www. emwa.org/webinars. Once registered, reminders are adapted to the user’s time zone. The system allows for sharing of handout material, polls, and surveys as needed. If you missed a webinar, you can still access it via the webinar’s archive. Simply click the respective “View the archive” link at the bottom of www.emwa.org/webinars. EMWA’s 2016 Webinar Programme Webinars are posted approximately 2 weeks after broadcast. We wish you a good and joyful learning In 2015 EMWA launched its webinar How are the webinars selected? experience and welcome your feedback at programme, providing members with an Several factors go into selecting webinar [email protected]. online training resource. Your feedback has topics. First, we select webinars based upon been valuable in helping us to shape an the feedback received from the audience of The webinar team exciting and extended programme for 2016, previous webinars. Additionally, we judge • Beatrix Doerr, Public Relations presented by inspirational speakers, all from attendee numbers the topics that are of Officer highly experienced in their field. special interest to medical writers. Second, • Patrick Bohan, Webinar Manager we try to cover a wide range of topics • Gail Zona, Editor What is a webinar? specifically related to medical writing as well A webinars is ‘a seminar or other as universal topics such as statistics and presentation that takes place on the internet, project management. We also intend to allowing participants in different locations provide updates on the latest guidelines, References to see and hear the presenter, ask questions, such as the new risk management plan 1. Dictionary.com. Definition for webinar. and sometimes answer polls.’1 summary template, which is expected to be [Accessed on December 30, 2015] published in mid-2016. Lastly, we plan for http://dictionary.reference.com/ Why is EMWA offering this? one disease-specific webinar per year. All browse/webinar?s=t What’s the purpose of a webinar presentations are peer-reviewed, and we and of the webinar series? ensure that the speakers are experts in their EMWA webinars allow for distance learning fields. and for updating and refreshing basic The current webinar programme can be medical communications skills and accessed at www.emwa.org/webinars, and knowledge, for newcomers and old hands the preliminary webinar programme for Beatrix Doerr alike. This is especially useful for subjects 2016 is summarised in the table. Clinical Research and Management that might not be practical or possible to be Consultant, Medical Writer presented during EMWA conferences. How do the webinars work? [email protected] Webinars also allow for timely training for How do I access live webinar specific issues as they arise, although this platforms and the webinar archive? Patrick Bohan means that the schedule may be adapted as Webinars usually last 1 hour, with time PharmaMar the year progresses. reserved for a short question and answer [email protected]
74 | March 2016 Medical Writing | Volume 25 Number 1 Emwa’s 2016 Webinar Programme
Month Webinar Title Speaker Webinar Description
January* Practical tips for effective project Alison Rapley Alison will share her experience of over 20 years in management and communication the medical writing department of a large CRO
February* Introduction to statistics Magda Joana Silva This webinar is intended for medical writers who want to understand more from statistics. It will include basics such as mean and median, p-value, confidence intervals, and risk ratios.
March First steps into freelancing – Jonathan Edwards Jonathan will reflect on his initial experiences, including initial experience considerations during the pre-freelancing ‘set-up’ period; approaches to contacting and winning clients; and how hopes and expectations met with reality during his first few months as a freelancer. He will also comment briefly on aspects of business set-up (such as tax status), but by necessity this part of the presentation will be UK-specific.
April Linguistic panel Amy Whereat, We will discuss linguistic topics such as sentence building, Alistair Reeves, and introductory phrases and link words, comparing and Laura C. Collada Ali contrasting, as well as some `language myths’. If you have any questions regarding grammar and style, please send them to [email protected] and we will endeavour to answer them during the webinar.
June Introduction to MedDRA coding Ursula Oestringer This webinar will provide an overview of Medical Dictionary for Regulatory Activities (MedDRA); an introduction to MedDRA coding; and some practical “how to” tips for those who might already have preliminary experience with MedDRA.
July New risk management plan Inga Abed The EMA’s Inga Abed will discuss the outcome of the EMA summary template pilot on RMP summaries which began in March 2014 and the updated template of the RMP summary, highlighting the main changes and guidance for completing it.
August Make Word behave as it should Gail Zona This webinar shows Word users how to solve some of the most common formatting problems that occur when working in a Word document, how to use Word’s formatting styles, how to deal with table of contents problems, and how to create internal and external links.
September Practical guide for writing clinical Beatrix Doerr This webinar will give practical, step-by-step guidance on how study protocols for medical devices to write a clinical study protocol for a medical device.
October Client management Kathryn White In this webinar, Kathryn addresses several questions she received during her time as EMWA Freelance Advocate, such as points to address at a first interview with a potential new client. She will also offer tips on gaining and retaining clients.
December The cardiovascular system Monica Meyer This webinar will focus mostly on the heart, its anatomy, physiology, and associated diseases such as aortic stenosis and coronary heart disease.
* Available in the webinar archive.
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 75 Photo: Yves Nato-Campanella Yves Photo:
Scientific integrity: editors on the front line THIRTEENTH EASE GENERAL ASSEMBLY AND CONFERENCE Strasbourg, France 10-12 June, 2016
Strasbourg is the capital and principal city of the Alsace region in eastern France and is the official seat of the European Parliament. The historic city centre, the Grande Île (Grand Island), was classified a World Heritage site by UNESCO in 1988. The University of Strasbourg is currently the second largest in France and the conference will take place in the superb facilities of the University’s School of Medicine. For more information, visit www.ease.org.uk/ ease-events/13th-ease-conference-strasbourg-france Plenary Speakers Surgery: from research to training and publishing – Jacques Marescaux, IRCAD, Strasbourg Role of institutions and editors – Lex Bouter, VU University Amsterdam Plagiarism – Michelle Bergadaà, University of Geneva PubPeer: implications for editors – Boris Barbour, PubPeer, Paris Organising committee Hervé Maisonneuve, Alison Clayson, Evelyne Decullier, Joan Marsh, Chris Sterken, Liz Wager
92 | March 2016 Medical Writing | Volume 25 Number 1 Out On Our Own SECTION EDITORS ✒ Kathryn White ● [email protected] ✒ Alistair Reeves ● [email protected] ✒ Sam Hamilton ● [email protected] Editorial Of interest in how fellow freelancers set up business and acquire work is always high, This is the last OOOO edited by Kathryn and in this issue we include Lizzie Sharpe’s the question pursued by Dawn Bentley, an White and Alistair Reeves, with Sam story about her experiences in Germany. executive coach, who feels that creating the Hamilton in the background. After many We also include Part 1 of Marion Alzer’s right impact on clients is something that years all three stepped down from their account of how she reluctantly became a freelancers often neglect. But since you freelance advocate activities at the con ference medical translator but then found that it alone are responsible for your impact, this is in The Hague, and have handed the torch actually opened up many unexpected doors something to consider very carefully. over to Julie Charlesworth and Satyendra for her, including becoming a freelancer and Please contact Julie (julie@ Shenoy, who will be running the Freelance also taking on medical writing jobs. atreeoflifesciences.com) or Satyen (sshenoy@ Business Forum and will also be looking after Are you having the impact you want to describescientific.de ) if you would like to this journal section in the future. build the business you truly deserve? This is contribute to OOOO
The start of a year in Germany as a freelance medical writer
“I’m moving to Germany.” “What?” “Yes” I repeated, “Moving to Germany.” “And what are you going to do there?” “I’m going freelance.” I said – the thought of which was scarier to me than moving to a country where I didn’t even speak the language.
So went the majority of conversations with friends, family, and colleagues as I broke the news that I would soon be moving to Munich. In theory, all a writer needs is their laptop, a few industry contacts, and a reasonable WiFi connection. And that’s it; you’re free to work wherever you choose. In reality, nothing prepared me for the barriers that would crop up on the other side of the UK border. invaluable, but no one could really tell me Challenge 2: The interview stage Challenge 1: Getting ready to go what steps I would need to take to work as a I come from healthcare advertising and – in Leaving a stable job at an agency I’d loved freelancer in Germany. I even rang the Germany at least – it seems that scientific working at for the past 3 years was by far the German consulate in one moment of and creative writing are kept very separate. most difficult decision. After that, I had to desperation. Luckily, I’d worked at an agency in the UK try to get to grips with what it meant to be a Before moving out here, I contacted where I was given the chance to develop freelancer. Not just a freelancer, but a various recruiters to see if they could help both skill-sets. freelancer in Germany. find me work and even got in touch with a Being able to be both a medical writer Being a complete newcomer to the game, few Munich-based agencies myself. A few and copywriter therefore seemed to be a rare I sought advice wherever I could. Calls with got back to me and I secured a couple of and valuable quality to my German umbrella agencies, recruiters, tax advisors. interviews before boarding the plane. interviewers; and the fact that my portfolio Chats with freelance colleagues proved spanned both creative and scientific work
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 77 really seemed to work in my favour. entirely in German. I had a German friend Medical translation – a Given my limited German capacities, I help me decipher the different sections and dead-end job or a gateway niched myself as a native English speaker, even she found it difficult to understand. to opportunity? Part 1 which I hoped might give me the edge over My biggest concern with becoming a in-house German writers on global Freiberufler was that this might close a lot When I was a teenage student studying accounts. This, however, didn’t always work of doors to me in England. It’s not English as a foreign language, I used to think to my advantage. uncommon for many UK agencies to have a translating was boring; utterly boring to be policy whereby they only work with precise. So, why did I follow a career as a Challenge 3: Ich spreche kein Deutsch freelancers who are registered as a limited professional translator and what made me (I don’t speak German) company or otherwise working through an change my mind? When working in-house for German umbrella organisation. agencies, this was never really an issue. After explaining that this was the most Dreams and aspirations Germans are incredibly helpful people and compliant way for me to operate as a It was during my first trip to England at the I found that most were more than willing to freelancer in Germany, some of my UK age of 13 that I fell in love with the English go out of their way to accommodate my clients were happy to work with me under language. Three years later, in 1980, my linguistic deficits. my Freiberufler status, but others weren’t. German school offered a 3-month student For example, agencies would have free- exchange programme in Vancouver and I lance contracts translated into English for Challenge 5: Getting down to business was selected as one of the fortunate me before I looked over them. And I was After the first couple of interviews, which I’d candidates. I realised that the ability to grateful to find that my multi-lingual coll - set up before leaving the UK, I was communicate with people in other countries eagues all switched to English for my benefit optimistic that it wouldn’t be long before I opened the door to the rest of the world for whenever I joined them on conference calls. was hit by a tidal wave of work that would me. The language barrier only presented real soon come flooding through my door. By the time I returned from Canada, I was problems when setting myself up as a At each interview I was greeted determined to teach foreign languages when freelancer. enthusiastically, complemented on my I left school. Unfortunately, job prospects for portfolio, and received great feedback. Then teachers were far from brilliant in Germany Challenge 4: Making friends with the tax … nothing. at that time. I had to face the fact that the man I waited and waited for the call but it was career I had dreamed of was not a realistic As I moved into freelancing, the hardest part almost 2 months after I moved before I got option if I wanted to avoid becoming an for me to grasp was who was going to take stuck into my first piece of work at a German unemployed university graduate. Being a care of my taxes. I would be working for agency. conference interpreter sprang to mind and it both UK and German agencies, but carrying Remote medical writing from old seemed like an exciting alternative. I out the work entirely from Munich meant industry contacts in the UK tided me over that all my taxes would have to be paid to the while I waited to get started. I began to cast German government. my net wider by applying for work in Most umbrella agencies are only able to different sectors, and in doing so sought out support you for up to 3 months if you are jobs in places I’d never thought to look living in another country. And if you are set before. Even, at one point, branching out up as a limited company then you’re only beyond pharmaceuticals into health and Are you having the impact able to invoice through this for up to 6 wellbeing for a Munich-based fitness brand. you want with your clients? months while living abroad. Now, I’m mostly brought in to work for But I needed someone to process my UK German companies on a project-by-project and German invoices for a whole year. I had basis, which means my contracts are short As a freelancer, or ‘entrepreneur’ you are the a few leads on some umbrella agencies who term. The majority of my income still comes leader in your business. You are the one who specialised in leasing out freelancers in from remote work, and I’m not busy all of makes things happen, so whatever happens European markets; but generally these were the time. in your business is down to you. Good client not willing to take me on unless I was But I’m ok with that. This year is more relationships are the key to your success. You contracted to work for at least a couple of about giving me a chance to explore life in are responsible for setting the tone of each months at a time. another country; learn how to live as a interaction and standards of behaviour for The solution I found was to register as a freelancer; and hopefully pick up more than those around you. This may sound scary, ‘Freiberufler’ (self-employed person) – a bit of German along the way. Tschüß! however, as the leader in your business you meaning I could invoice my clients directly are on show all of the time. People are using my tax and VAT numbers – and I hired Correspondence to: always watching you and making a German tax advisor to take care of my Elizabeth Sharpe assessments, so it’s not good enough to just German taxes. Munich, Germany show up and hope for the best. Whether you To do this I first had to fill out a form [email protected] like it or not, you and your business are from the Finanzamt (the ‘Fragebogen zur https://elizabeth-sharpe- judged by the impact you have on others. steuerlichen Erfassung’) – this is long, and dglu.squarespace.com So, the question is, are you having the
78 | March 2016 Medical Writing | Volume 25 Number 1 imagined myself travelling from one later completed medical translations specific programme in linguistics with a focus on international conference to another, helping to each body system to gain competence in second language teaching. To finance these people communicate with one another. I medical terminology and how to convey the studies, I taught German in the Department applied to the “Department of Applied meaning of medical texts. The examining of Foreign Languages. Linguistics” at the University of Mainz in board consisted of professional translators, When I returned to Germany in 1991 I Germersheim to study English and Spanish a physician and a pharmacist and ensured applied for a position in the pharmaceutical and I was accepted. that after nine semesters I was proficient in industry. Fortunately, the headquarters of a “medicalese” and worthy of the degree German pharmaceutical company with Change and choice “Diplom-Übersetzerin”. affiliates all over the world were looking for What seemed fascinating in theory turned a medical translator. The company’s Foreign out to be disappointing in practice. I just Work experience Language Services group formed part of the couldn’t get the hang of sitting in a booth, To gain work experience in the real world, I Scientific Documentation Department and listening to someone speak in one language applied for internships in the Medical consisted of six people who worked in four and conveying what was being said in Department of a pharmaceutical company different languages. Our group was resp on - another language. After umpteen attempts while I was still studying. I was introduced sible for translating and coordinating to master the challenges of simultaneous to drug research and development at a time translations mainly in the following areas: interpreting, I eventually got to grips with when the company was granted marketing pre-clinical, clinical and regulatory; drug the fact that all those international authorisation for a new drug which later manufacturing; corporate affairs and conferences would have to take place became a blockbuster product. My respon- international relations. Other tasks also without me. sibilities included translating regulatory included review and correction of This experience did not discourage me documents and correspondence with translations done by external translators as from wanting to pursue a career in lang - authorities, medical and marketing materials well as terminology work. uages. Fortunately, my university offered as well as press releases. translation studies as a suitable option and In Part 2, I will describe despite my earlier reservations I switched Language proficiency how I became freelance. over to translation. The course was To improve my command of English, I structured to include two foreign languages decided to live in an English-speaking Correspondence to: and an additional subject such as law, country and so I participated in exchange Marion Alzer economics, engineering or medicine. I chose programmes with the University of North Pharma Communications GmbH medicine and thoroughly enjoyed this Carolina at Charlotte (UNCC) and Erding, Germany subject. I attended medical lectures that Louisiana State University (LSU) at Baton [email protected] focussed on the various body systems and Rouge. At LSU, I also completed a Master’s www.marion-alzer.de
impact you want to build the business you portrays a clear message, if you are thinking questions to ask yourself are: truly deserve? Have you even considered the one thing but saying another, people will • What is your current relationship with impact you want to have? pick this up. them? In my experience most people haven’t! How often do you go into a meeting with • What is the history between you both (or a clear intention of what you want to achieve between you and their department)? How do I create impact with my clients? from it? • How do you want this relationship to There are two principles to have in mind Leadership is about connection, so you develop? when you are considering your personal need to make sure you connect in some way impact with clients: with everyone you meet – and yes I did say Once you have thought about these you can 1. Your intention everyone. Of the people you come into then think about what you want from a 2. Your attention contact with, you never know who could meeting with them – whether this is in introduce you to a potential new client or person or remotely by telephone. What Principle 1: Intention perhaps they know one of your existing outcome do you want to achieve? Let us start by looking at intention. There’s clients. a phrase I often use which is ‘we judge So, how do you create that connection? Case study ourselves by our intention and we judge To connect you have to take the other Here’s a case study from my coaching others by their impact.’ Being really clear person into account and should be part of practice to give you an example of how about your intention helps you focus your your consideration when thinking about considering your intention can make a mind and your energy. To be effective your your intention. Before any meeting or difference: actions must match your intention. This interaction with a client, some good Carol was a newly appointed Operations
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016 | 79 connecting with me as he described a situation he wanted help with. After some feedback from me, and some practise at improving his attention, we replayed the situation. There was a marked difference. He had slowed down, he was making eye contact, his breathing had slowed down and I felt he was really listening to me. Now, he was working with me at my pace and was fully present and engaged with me. After the session he applied these principles at work and found his team became more engaged, he developed a deeper connection with his customers and as a consequence got better results.
What can I do to create impact with my clients? To help you create more impact during your business interactions, I’ve listed a few things Director and very experienced in her field. • Is there something you want to learn? to consider before any client meeting: In a relatively short space of time she had • If there is a topic you’re discussing with • Set an intention for every interaction or mastered how to lead her team effectively so the client, do you simply want to meeting you go to. that they were aligned with her vision. understand it or learn more about it? • Consider how you want to be seen and However, she realised she hadn’t been • If so, what is it about that topic that you adjust the tone of your voice and body giving her customers (i.e., her stakeholders) want to learn/understand? posture to support this. The more the attention they deserved in order to • Is there an idea you want to share with relaxed you are, the deeper your vocal engage with them and ‘get them on board’. the client to get some feedback on it? tone and this will be reflected in your This was particularly important if she body language too, thus giving you a wanted the changes she was implementing Principle 2: Attention greater air of confidence. to work. ‘Energy flows where attention goes’ • If you are having a conversation with Together, we explored what her Where do you put your attention? When someone focus your full attention on that intentions were and what became clear was you are in a meeting or with a client how person and the conversation – really that she was ‘just’ going through the often are you waiting to speak rather than listen to what they are saying. motions. She was using all the right words actually listening with an intention to • If it’s a meeting you are in, do the same when she spoke with her customers, but she understand what the other person is saying? and focus on every person as they speak. didn’t sound as though she meant them. I If personal impact means aligning your sensed that her mind was on other things so intention to how you act, then you have to Personal impact is what others feel when she was working with her customers out of be attentive to those you are working with. they are with you and this will be reflected a sense of duty rather than to build That means that you are fully present in that in the quality of the relationships you build. relationships. moment. I am sure you have been with If you want to take your business to a new We went on to explore how she wanted someone and thought that they were not level, practice these skills regularly and feel the relationships to develop. By being really with you, their mind was somewhere the difference it makes! focused on her intention, in just a few else. When someone seems distracted like months, she’d built strong relationships and this, say in a meeting, you notice it. So, it will Dawn Bentley is an Executive Coach trusted allies. come as no surprise to you that people will working with leaders to be authentic in their So, before you have any contact with notice it too when you are not paying style and develop powerful teams. If you’d your clients, really think through what it is attention! like to follow her posts please connect with you want and how you want to be seen. her on LinkedIn Facebook, Twitter or sign Case study up for her monthly newsletter here. Here are a few examples of things you could This principle was a real light bulb moment consider as intentions to get you started for one of my clients as shown by the before any client interaction: following case study. Correspondence to: • Do you simply want to connect and build When I’m coaching I encourage my Dawn Bentley rapport with the person? At the start of a clients to bring real situations they are facing Aurora Business Coaching and relationship this is critical. into the session. On one coaching occasion Consulting UK • Is there a particular result you want from I picked up that my client Paul, seemed to [email protected] this interaction? be rushing ahead and not necessarily www.aurora4success.co.uk
80 | March 2016 Medical Writing | Volume 25 Number 1 Themes of forthcoming issues of Medical Writing
June 2016: ‘Medical Communication’ This will include articles on careers in medical communications, evolving best practices, continuing medical education, communication strategy, and medcomms agencies. Guest Editor: Amy Whereat. This issue is now closed to new submissions.
September 2016: ‘Statistics’ This will include articles on presenting and understanding basic statistics for medical writers. The deadline for feature articles is June 13, 2016
December 2016: 'Medical Education' This will include articles on running advisory boards and preparing slide kits, conference presentations, and other learning resources. If you have ideas for themes or would like to discuss The deadline for feature articles is September 12, 2016 any other issues, please write to [email protected].
www.emwa.org Volume 25 Number 1 | Medical Writing March 2016