Medical Writing Management Vol

Total Page:16

File Type:pdf, Size:1020Kb

Medical Writing Management Vol Vol.Vol. 18, 20, No. No. 2, 4, 2009, 2011, ISSNISSN 1854-8466.1854-8466. Medical writing management Vol. 20, No. 4, 2011 The Write Stuff EMWA Executive Committee Journal insights The Write Stuff is the offi cial publication of the European Medical Writers Asso- ciation. It is issued 4 times a year and aims to provide EMWA members with relevant, President: informative and interesting articles and news addressing issues relating to the broad Rita Wellens arena of medical writing. We are open to contributions from anyone whose ideas can Wellens Clinical Research Consulting complement these aims, but opinions expressed in individual articles are those of the Rillaar, Belgium authors and are not necessarily those held by EMWA as an association. Articles or ideas should be submitted to the Journal Editor (see below) or another [email protected] member of the Editorial Board. Vice President: Subscriptions Please contact Maney Publishing’s Customer Services & Subscriptions Team at sub- Susan Batti [email protected] for subscription information or view http://www.maney. Premier Research Germany Ltd., co.uk/journals/mew. Darmstadt, Germany, [email protected] Instructions for contributors • The Write Stuff typically publishes articles of 800–2500 words although long- er pieces or those with tables or graphics will be considered. Treasurer: • All articles are subject to editing and revision by the Editorial Board. Any chang- Gillian Pritchard es will be discussed with the author before publication. Sylexis Limited • Submissions should include the full address of the author, including the telephone Dundee, UK and fax numbers and e-mail address. Suitable quotes for side boxes can be indi- [email protected] cated or they can be selected by the Editorial Board. • Material should be submitted by e-mail as an MS Word fi le using Times New Roman (or equivalent), 10 point size, and single spacing. Honorary Secretary: Timelines Sarah Choudhury Month Deadline Medical writer distributed for receipt of articles Letchworth Garden City, UK March 28th November [email protected] June 13th February September 4th June December 3rd September Public Relations Offi cer: Farid Khalfi Advertising rates Guerbet For advertising information please see http://www.maney.co.uk/journals/mew or Roissy, France contact Gaynor Redvers-Mutton at [email protected] [email protected] Behind the press Website Manager: The Editorial Board Shanida Nataraja Associate editor Phil Leventhal Axon Communications London, UK Board members Chris Priestley [email protected] Richard Clark Ursula Schoenberg Margaret Gray Andrea Rossi Education Offi cer: Iain Patten Joselita T. Salita Jo Whelan Textpharm Ltd Columnists Alistair Reeves Oxford, UK Wendy Kingdom [email protected] Alison McIntosh Karin Eichele Dianthus team Gabriele Berghammer Conference Director Greg Morley Sunethra Wimalasundera Freelance forum columnists Raquel Billiones Medical writer Sam Hamilton Hatfi eld, UK Kathryn White [email protected] Anu Alahari Journal Editor Elise Langdon-Neuner Baxter BioScience Vienna, Austria [email protected] EMWA Head Offi ce Chester House, 68 Chestergate, Macclesfi eld, Cheshire, SK11 6DY, UK Disclaimer Tel: +44 (0)1625 664534, Fax: +44 (0)1625 664510 The views and opinions expressed in The Write Stuff are those of the individual [email protected] authors and do not necessarily represent those of the European Medical Writers As- EMWA website: www.emwa.org sociation or its Executive Committee. The Write Stuff is printed on 100% recycled paper. 210 The Journal of the European Medical Writers Association The Write Stuff Vol. 20, No. 4, 2011 TOC Medical writing management Vol 20, No. 4, 2011 Roy G. Leventhal Freelance Section Getting the most from your staff through empowerment 216 Kathryn White A leap of faith—The power of Barrie Dubois life-coaching 251 Fostering collaboration 219 Raquel Billiones Diarmuid De Faoite Out of Hours: Writing an What classic and modern annual family report 253 business literature has to say about motivation—And how you Diana Raffelsbauer can apply these theories to Going freelance: your own life 222 The last of a series of interviews 254 Martin Robinson Making the transition from operations to management 225 Virginia Watson Cover photograph Practical tips on moving up The French conductor and composer through the ranks of management 227 François-Pierre Descamps at the rehearsal of one of the 10 operas and 2 pantomimes from the project An Interview with Julia-Forjanic “1001 night” by the company Klapproth: On starting and SireneOperntheater in August and managing a medical writing agency 229 September 2011 in Vienna, Austria. www.sirene.at Julia Cooper More photos from the opera can been The Development Safety Update Report viewed at http://gallery.me.com/nadja. (DSUR): A new regulatory document meister intended to harmonise periodic safety Cover photograph from Nadja reports for clinical trials 232 Meister ([email protected]) Graphic design on pages 230, 231, Alison Rapley 237, 239, 241, 247, 256 and 257 by Impact of the new European Anders Holmqvist ([email protected]) pharmacovigilance legislation on medical writing 235 Regular features From the Guest Editor’s desk 212 Maria Fernandez-Piera Message from the President 214 Webscout 244 The European Marketing In the bookstores… 245 Authorisation process: Journal watch 246 Responding to regulators’ questions 237 Good writing practice 248 Words, Grammar & Co 258 Ursula Schoenberg For regulatory writers 260 Biomedical publishing shorts 261 Tricky terrain: Medical journalism 262 Healthcare and social media 240 Manuscript writers’ corner 267 The Journal of the European Medical Writers Association 211 Vol. 20, No. 4, 2011 The Write Stuff From the Guest Editor’s desk Management in medical writing by Phil Leventhal Even if you are not a manager, management is something The basic principles of good management have been you need to deal with in one way or another. We all must known for millennia. Mencius, a Chinese philosopher born manage medical writing projects, and sometimes we are in 372 BCE, wrote that “the most important asset of a state called on to manage people in a multifunctional team. or organisation is human capital” [1]. More than that, he All medical writers, including freelancers, should there- believed in the inherent goodness of people. This is a great fore have clear ideas on how to manage people in a way place to start to understand management…even if some that moves projects forward rapidly and effectively. Man- companies or managers do not act on this basis or have not agers in a company setting, of course, have many addi- considered what this implies. tional responsibilities, such as staffi ng, strategic planning, The idea of a special issue on management in medical writ- and fi nancial and resource planning. From experience, we ing came about through discussions that I had with my fa- all probably have a sense of what good management is, ther, Roy Leventhal. After over 50 years of experience as an but this special issue of The Write Stuff takes some of the employee and manager in different companies, he has use- guesswork and intuition out of what this entails. ful insight about what makes for good management. In his article, he advocates empowering employees by creating a bottom-up problem-solving system (page 216). This kind of empowerment gets the most out of employee expertise, maintains their motivation, and adds value to the company. Diarmuid De Faoite (page 222) adds to this theme of mo- tivation. In his article, he explains how ideas of motivation have evolved since the early 20th century from considering employees as machines motivated exclusively by a desire for high wages to the more modern view that a desire for self-fulfi lment drives motivation. Collaboration is a management word that we hear a lot when working on team projects. Barrie Dubois, an organi- sation specialist in the Silicon Valley area of California, explains what collaboration really means and how to foster it (page 219). She explains that sustainable collaboration implies not acquiescence but confl ict, and she provides tools for creating an environment where these confl icts can be quickly resolved. Two articles in this issue discuss what a medical writer needs to know to become a manager. Martin Robinson, Principal Director at the International Academy of Clinical Research (page 225) writes that being a good writer does not imply that you will be a good manager. Becoming a good manager requires getting out of your ‘comfort zone’ and learning a completely new set of project and people management skills. Virginia Watson, Company Director of Dulcamara Ltd., discusses what she learned from many years as a manager in multinational corporations (page 227). Like Martin Robinson, she emphasises the need to learn new skills, and she breaks these down into three Painting of Mencius, a Chinese philosopher born in 372 BCE. After Confucius, he was probably the second-most important philosopher in Chinese history. He areas: operations, personnel and strategic. believed in the inherent goodness of people and that “the most important asset of a state or organisation is human capital” [1]. To learn about managing a medical writing agency, The Source: http://www.wikipedia.org Write Stuff interviewed Julia Forjanic-Klapproth, Senior 212 The Journal of the European Medical Writers Association The Write Stuff Vol. 20, No. 4, 2011 From the Guest Editor’s desk Partner and CEO of Trilogy Writing & Consulting and After reading these articles, I came to the same conclusion former president of EMWA (page 229). Julia’s advice and as Mencius: people are a company’s greatest asset. Good experiences are of great value not only to EMWA mem- management means trusting people and giving them the bers wanting to start their own companies but also to med- opportunity and encouragement to contribute. This issue ical writing agencies and departments wanting to make of The Write Stuff should help medical writers make sev- improvements in their management style.
Recommended publications
  • Medical Writing Services 1 Medical Writing Services Experts Guiding You Through Your Journey
    PAREXEL® CLINICAL RESEARCH SERVICES MEDICAL WRITING SERVICES 1 MEDICAL WRITING SERVICES EXPERTS GUIDING YOU THROUGH YOUR JOURNEY PAREXEL’s Medical Writing Services team is one of the largest and most experienced in the biopharmaceutical industry, providing a wide range of high-quality documents from Phase I through to post-marketing and beyond. We can offer medical writing services for standalone projects, functional service partnerships or as a fully integrated service within our clinical research programs. MEDICAL WRITING PROJECTS COMPLETED: 2300 by PAREXEL’s Medical Writing Services team from 2009 to 2014 2 PAREXEL MEDICAL WRITING SERVICES ICF PRODUCES HIGH QUALITY DOCUMENTS ACROSS THE PRODUCT DSUR, Protocol IB LIFE CYCLE IND AR The Medical Writing Services group at PAREXEL is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation required to support your product Key: development efforts. We offer fast turnaround and a ICF = Inform Consent Form flexible, efficient process for any project large or small. IB = Investigator Brochure DSUR = Development Safety Update Reports IND AR = Investigational New Drug Annual Reports CSR = Clinical Study Report CTRS = Clinical Trial Result Summary PBRER = Periodic Benefit-Risk Evaluation Report PSUR = Periodic Safety Update Report PADER = Periodic Adverse Drug Experience Report CTD = Common Technical Document NDA = New Drug Application 3 Taking a new medicine or medical device from concept PAREXEL’s Medical Writing Services department to market requires writing and submitting hundreds of includes a large number of scientists with significant thousands of pages of documentation. To minimize time expertise in the therapeutic areas that are important to market, these documents and reports must be to you.
    [Show full text]
  • Professional Medical Writing Support and the Quality of Randomised Controlled Trial Reporting: a Cross-Sectional Study
    Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study William Gattrell, Sally Hopewell, Kate Young, Paul Farrow, Richard White, Elizabeth Wager and Christopher Winchester MedComms Networking Event 4 May 2016 Paul Farrow DPhil CMPP ! Communications Director at Oxford PharmaGenesis −" More than 10 years of experience in medical communications −" Contract Global Publications Lead for a top-10 pharma company −" Head of the PharmaGenesis Publications Ethics, Planning and Research group −" GPP3 reviewer −" Guest lecturer on GPP at the University of Oxford, UK 2 Medical writing is misunderstood and sometimes gets bad press 3 Our industry bodies say … “Involving medical writers may therefore raise the standard of publications and accelerate the writing and publication process”1 “... medical writers can often improve the efficiency and effectiveness of manuscript preparation by working with the research team to develop clear and concise manuscripts in a timely fashion”2 … but is there any evidence to support these statements? 1. Jacobs A, Wager E. Curr Med Res Opin 2005;21:317–22; 2. Norris R et al. Curr Med Res Opin 2007;23:1837–40 4 Available evidence “When professional medical writers help authors prepare manuscripts, these manuscripts are less likely to be retracted for misconduct,22 are more compliant with best-practice reporting guidelines,23 and are accepted more quickly for publication24” Woolley KL et al. Poor compliance with reporting research results – we know it’s a problem … how do we fix it? Curr Med Res Opin 2012;28:1857–60 22. Woolley KL et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study.
    [Show full text]
  • Medical Writing June 2019, Volume 28 Number 2
    Biosimilar development – an overview Diana Radovan Trilogy Writing and Consulting GmbH, Frankfurt am Main, Germany Correspondence to: Diana Radovan Senior Medical Writer Trilogy Writing and Consulting GmbH, Falkensteiner Str. 77, 60322 Frankfurt am Main, Germany +49 69 138 2528 56 [email protected] Abstract Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of biological molecules, not full Since biologics and “sameness”. Biosimilar registration follows a biosimilars are created in strictly regulated pathway based on a totality- of-evidence approach. This article critically living cells, they cannot discusses the particulars of biosimilar devel - be chemically synthesised opment, including the continuous develop - like generic drugs. ment of regulatory guidelines, familiarises readers with biosimilar-specific terminology, addresses the typical challenges of writing biosimilar dossiers, and summarises future directions in biosimilar development in the and biosimilars are created in living cells, they biological medicine already approved in the EU, context of a changing competitive landscape. cannot be chemically synthesised like for which there are no clinically meaningful After reading this article, medical writers with conventional drugs and their generics. differences to the reference medicine in terms of different backgrounds, including those While a biosimilar candidate and an safety, quality and efficacy. 2 In the US, a previously unfamiliar with key aspects of originator biologic share the same amino-acid biosimilar product is defined as a biologic biosimilar development, should be able to sequence, they can never be identical, due to the product approved based on demonstrating that better understand and apply these guidelines inherent variability of complex biological it is highly similar to an US FDA-approved in their daily biosimilar work.
    [Show full text]
  • The 5 Levels of Evidence in Evidence-Based Medicine
    evidence-based medicine the 5 levels of evidence in evidence-based medicine DISCLAIMER This material is provided for informational purposes only. The material does not constitute legal or professional advice nor does it necessarily represent the position of the Tech Observer Group. In case of doubts relating to this material, please consult your company's internal policy on scientific publications. hello there! Ever thought that scientific publications are too complex? Or that publishing your research seems too daunting a task? To make things easier, we have developed a series of bite-sized guides covering a range of topics on scientific publications. Let's make the complex simple. tech Observer medical communications EVIDENCE-BASED MEDICINE Strongest More and more healthcare professionals are consulting Evidence the literature and gathering research evidence to inform their clinical decisions. However, not all published evidence are equally convincing. Meta- analysis Level 1 The evidence pyramid to the left presents a hierarchy systematic of study types. The higher up the pyramid, the review more rigorous the study methodology and randomized trial hence the more likely it is that the study design can minimize the effect of 2 cohort study bias on the study results. 3 case-control study Here is a quick overview of the 5 levels 4 Case series/report of evidence in evidence-based 5 Weakest medicine. expert opinion Evidence 55levels of evidence in evidence-based medicine level 1 High quality randomized controlled trials and systematic reviews and meta- analyses of randomized controlled trials level 2 Cohort studies and systematic reviews of cohort studies level 3 Case-control studies and systematic reviews of case-control studies level 4 Case series and case reports level 5 Expert opinion and narrative reviews Strongest Evidence WRAPPING UP The evidence-based Meta- medicine movement has given analysis Level 1 publications of research an systematic review increasingly influential role in clinical practice.
    [Show full text]
  • Medical Writing Professionalism: Competency Modeling, Application, and Examination
    Medical Writing Professionalism: Competency Modeling, Application, and Examination AMWA Annual Meeting Washington, DC November 2018 David Clemow, PhD, MWC Advisor Scientific Communications Strategy Eli Lilly and Company Friday, November 2, 2018, 2:00 - 3:30 pm Renaissance Washington DC Downtown Hotel Congressional B ©2018 1 Medical Writing Professionalism – Agenda Competency Model Application of Competency Model Certification Examination Abbreviations: DIA = Drug Information Association KSABs = knowledge, skills, abilities, behaviors MW = medical writer MWC = Medical Writer Certified 2 Medical Writing Competency Model Content – Agenda Introduction to competency Background on model Content organization Work functions Knowledge, skills, abilities, behaviors (KSABs) Additional information 3 Introduction – What is Competency The ability of an individual to perform a job successfully A competent professional • Is qualified to perform a specific role • Has ability to perform a specific role • Uses combination of KSABs to perform job successfully Hanging a plaque on the wall that says medical writer • No; thus, • Competency model (define the profession) • Certification development (test individual on competency) 4 Introduction - What is a Competency Model Defines what competence looks like for a given profession Outline of functions (tasks, activities) that person in role must perform to be successful Professionally agreed upon list of KSABs that define successful job performance 5 Background – Model History Developed by Drug Information Association
    [Show full text]
  • How to Write an Introduction and Methods of a Systematic Review of Literature Ashar Muhammad Malik Aga Khan University, [email protected]
    eCommons@AKU Community Health Sciences Department of Community Health Sciences October 2014 How to write an introduction and methods of a systematic review of literature Ashar Muhammad Malik Aga Khan University, [email protected] Follow this and additional works at: http://ecommons.aku.edu/pakistan_fhs_mc_chs_chs Part of the Health Services Research Commons, and the Medical Education Commons Recommended Citation 1208 LEARNING RESEARCH How to write an introduction and methods of a systematic review of literature Muhammad Ashar Malik Writing systematic review in English language is intervention such as its clinical presentation and challenging for those whose first language is other than management. The third part of the introduction may English and those who are not primarily trained on include the efficacy of the intervention/therapy on the writing skill such as medical doctors.1 The guidelines to target population. The last part of the introduction may write and publish a systematic review are usually specific provide justification to carry out the systematic review. It to scientific journals or such research groups that publish should identify how much is already known and what systematic reviews. Systematic reviews are accepted in needs to be known.4 most of the medical journals. The top 100 most cited systematic reviews in medical sciences research between For writing the methods section of the systematic review 1977 and 2008 have mainly been published in Journal of the Cochrane guideline and PRISMA are quite explicit. American Medical Association (JAMA), British medical Both of these guidelines have recommended headings journal (BMJ) and the Lancet.2 These journals provide (but not mandatory) to be covered in the methods part.
    [Show full text]
  • An Insider's Insight Into Literature Searches
    An Insider’s Insight into Literature Searches Searching the literature can take various forms, ranging from a quick scan of recent publications to a formal, systematic interrogation of all available data sources to establish the scientific consensus on a specific topic. In these days of online journal databases, the relative ease of conducting a search means that they often start informally with no thought-out search strategy or defined goal. A long list of articles can be generated almost instantaneously, but what did you miss and how long will it take to review the data? How easily can the search strategy be repeated and adapted to obtain a more complete and refined set of references? We offer some insights from the Niche medical writing team who have been conducting literature searches for their clients since 1998. Copyright © 2016 Niche Science & Technology Ltd, UK 1 Before you start Prepare to succeed • Establish a formal plan for your literature • Your searches will create outputs in the form of search if you propose to do anything more than lists of publications. Decide what information conduct a cursory review of the literature you need to record about each reference in order to help determine its relevance, how you • Know what you want to achieve so you avoid will store the information and how you will endless futile or repetitive searching. Set ‘score’ the overall efficacy of a search strategy yourself an objective and identify an endpoint that qualifies whether or not you have achieved • Know something about your subject area your goal before you decide on the operational parameters of your search; consider the • Ensure you have access to an appropriate coverage history in the literature, controversies, search engine as different databases will specialist journals, sub categories, etc.
    [Show full text]
  • Inside Research Ghostwriting Prevalence Among AMWA and EMWA Members (2005 to 2014)
    Volume 31 Number 1 / Spring 2016 WWW.AMWA.ORG ELECTRONIC EDITION Inside Research Ghostwriting Prevalence Among AMWA and EMWA Members (2005 to 2014) Meta-analyses: Merits, Limitations, and Application of the PRISMA Statement Practical Matters Ensuring an Effective Quality Control Process What Medical Writers Should Know About Drug Access/Reimbursement in the United States and Preparation of AMCP Dossiers THE OFFICIAL JOURNAL OF THE AMERICAN MEDICAL WRITERS AssOCIATION, THE RESOURCE FOR MEDICAL COMMUNICATORS AMWA ENGAGE Connect and Collaborate Join Discussions Share Resources Get Engaged AMWA COMMUNITY engage.amwa.org Register Early for Best Rates Medical Writing & The preeminent education 2016 Communication and networking event Conference for medical writers and AMWA communicators. OCTOBER 5-8|DENVER, CO Trends and Opportunities for Medical Communicators www.amwa.org/conference V31 N1 50 SPRING 43 Confidence limit Contents 2016 40 95% CI 33 Point estimate 30 90% CI 25 Confidence limit 20 99% CI 10 RESEARCH Responders Percent 3 28 Ghostwriting Prevalence Among AMWA and EMWA 0 Members (2005 to 2014) � Cindy W. Hamilton and Adam Jacobs 12 Meta-analyses: Merits, Limitations, and Application of the PRISMA Statement � M. Denise Daley 20 PRACTICAL MATTERS Ensuring an Effective Quality Control Process � Lima Chutkan What Medical Writers Should Know About Drug Access/ 24 Reimbursement in the United States and Preparation of AMCP Dossiers � Linda L. Rice and Jessie Wolfe Galson 30 28 YOUR STATS REFRESHER! Confidence Intervals � Thomas M. Schindler 30 SOCIAL MEDIA Tips for Searching Social Media � Cynthia L. Kryder 32 2016 CONFERENCE PREVIEW New for 2016: AMWA’s Medical Writing & Communication Conference � Yeshi Mikyas 34 AMWA NEWS From the President � Stephen N.
    [Show full text]
  • A Career Guide to Medical Writing
    A Career Guide to Medical Writing Ever thought about being a medical writer? If you are a strong communicator and want to use your scientific skills and knowledge, then this might be the career for you. Written by 2 What is medical writing? Sally Jackson and Raquel Billiones Medical writing is about clearly communicating clinical and scientific data Reviewed by the and information in written form. The job draws on diverse skillsets and roles EMWA Executive Committee and Ananya Malladi vary widely. For example: ● By pitch: Medical writers pitch information to a wide range of audiences, Contents from clinical professionals, to drug regulators, to lay audiences. 1 Purpose of this guide 2 ● By work format: Roles range from taking notes in conferences, preparing 2 What is medical writing? 2 presentations, producing and editing regulatory documents and 3 What are the different types of medical writing? 3 manuscripts, marketing communications, and educational materials for 3.1 Regulatory medical writing 3 different target groups, translations, and journalism. 3.2 Medical communications 3 ● By individual writers attributes: For example, language skills will enable 3.3 Translation 4 you to work as a translator or editor, statistical skills will enable you to 3.4 Other types of medical writing 4 analyse and interpret data. Specific skills in a certain therapeutic area 4 What skills and qualifications do I need? 4 might be beneficial in finding your niche. Writers come from diverse 5 Where do medical writers work and what do they do? 5 backgrounds and there are plenty of opportunities to find your area of 5.1 Employment within an organisation 5 expertise.
    [Show full text]
  • (FAQ) About Statin Adverse Effects
    Frequently Asked Questions (FAQ) about Statin Adverse Effects Table of Contents Frequently Asked Questions about Statin Adverse Effects ................................................ 3 Introduction......................................................................................................................... 3 What are the names of the Statin drugs?......................................................................... 4 What is the “Statin Study”? ............................................................................................ 4 Where can I look to find information on research studies of statin drugs? .................... 5 Why does my physician have such a difficult time believing that my physical problems might be an adverse effect of Lipitor or one of the other statins? .................................. 5 OK, I understand the doctor’s need to read clinical study results, but where can I find out what other people are experiencing in plain language, and maybe share my experiences?....................................................................................................................7 Are there any books on the topic?................................................................................... 7 What are the Liptior warnings and side-effects listed by the manufacturer on the physicians’ information?................................................................................................. 8 What are the Lipitor Adverse Events in Placebo-Controlled Studies listed by Pfizer in the Physician’s
    [Show full text]
  • Professional Medical Writing Support
    F1000Research 2017, 6:1489 Last updated: 22 SEP 2017 RESEARCH NOTE Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals [version 2; referees: 2 approved] Ira Mills 1, Catherine Sheard2, Meredith Hays3, Kevin Douglas3, Christopher C. Winchester 4,5, William T. Gattrell6,7 1PAREXEL International, Hackensack, NJ, 07601, USA 2Department of Archaeology and Anthropology, University of Bristol, Bristol, BS8 1TH, UK 3Department of Medicine, Uniformed Services University, Bethesda, MD, 20814, USA 4School of Medicine, Pharmacy and Health, Durham University, Stockton on Tees, TS17 6BH, UK 5Research Evaluation Unit, Oxford PharmaGenesis Ltd, Oxford, OX13 5QJ, UK 6Oxford Brookes University, Oxford, OX3 0BP, UK 7Ipsen Pharma, Abingdon, OX14 4RL, UK v2 First published: 16 Aug 2017, 6:1489 (doi: 10.12688/f1000research.12268.1) Open Peer Review Latest published: 14 Sep 2017, 6:1489 (doi: 10.12688/f1000research.12268.2) Referee Status: Abstract Background: In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Invited Referees Consolidated Standards of Reporting Trials (CONSORT). We set out to 1 2 determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts. Methods: Using data from a previously published cross-sectional study of 463 version 2 report report articles reporting randomized controlled trials published between 2011 and published 2014 in five top medical journals, we determined the association between 14 Sep 2017 professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test. version 1 Results: The mean proportion of adherence to CONSORT for Abstracts items published report report 16 Aug 2017 reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30).
    [Show full text]
  • Industry-Corrupted Psychiatric Trials1
    Psychiatr. Pol. 2017; 51(6): 993–1008 PL ISSN 0033-2674 (PRINT), ISSN 2391-5854 (ONLINE) www.psychiatriapolska.pl DOI: https://doi.org/10.12740/PP/80136 Industry-corrupted psychiatric trials1 Jay D. Amsterdam1, Leemon B. McHenry 2, Jon N. Jureidini3 1Depression Research Unit, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania 2Department of Philosophy, California State University, Northridge, California 3Critical and Ethical Mental Health Research Group, Robinson Research Institute, University of Adelaide, Australia Summary The goal of this paper is to expose the research misconduct of pharmaceutical industry- sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepre- sentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine. Key words: antidepressants, citalopram, clinical trials, depression, ghostwriting, key opi- nion leaders, paroxetine, research misconduct, selective reporting Introduction As former editor of the New England Journal of Medicine, Marcia Angell reported in 2008: Over the past 2 decades, the pharmaceutical
    [Show full text]