DOCSLIB.ORG

The History and Current State of Publication Bias and Inadequate Trial Transparency in the Health Sciences”

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
The History and Current State of Publication Bias and Inadequate Trial Transparency in the Health Sciences” References for the Medical History Interest Group presentation “The History and Current State of Publication Bias and Inadequate Trial Transparency in the Health Sciences” About AllTrials. AllTrials website. http://www.alltrials.net/find-out-more/about-alltrials/. Accessed/link last verified December 3, 2014. Adams B. The pioneers of transparency. BMJ. 2015;350:g7717. doi: 10.1136/bmj.g7717. Ahmed I, Sutton AJ, Riley RD. Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey. BMJ. 2012;344:d7762. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003;290(7):921-928. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289(4):454-465. Bhandari M, Busse JW, Jackowski D, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ. 2004;170(4):477- 480. BMJ. 2012 Jan 7;344(7838). BMJ. 2012 Nov 3;345(7881). Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med. 2010 Aug 3;153(3):158-66. Buchkowsky SS, Jewesson PJ. Industry sponsorship and authorship of clinical trials over 20 years. Ann Pharmacother. 2004;38(4):579-585. Castellani J. Are clinical trial data shared sufficiently today? Yes. BMJ. 2013;347:f1881. Chalmers I, Glasziou P, Godlee F. All trials must be registered and the results published: academics and non-commercial funders are just as guilty as industry. BMJ. 2013;346:f105. Chalmers I, Vallance P. Secure use of individual patient data from clinical trials. Lancet. 2013 Sept 28;382:1073-1074. Chalmers I. Proposal to outlaw the term “negative trial”. BMJ. 1985 March 30;290:1002. Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990 Mar 9;263(10):1405-1408. Chan A. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ. 2012;344:d8013. Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004 May 26;291(20):2457-2465. Cohen D. Complications tracking down the data on oseltamivir. BMJ. 2009 Dec 12;339:b5387. Cohen D. Rosiglitazone: what went wrong? BMJ. 2010 September 6;341:c4848. doi: http://dx.doi.org/10.1136/bmj.c4848. Committee on Finance, United States Senate with Max Baucus, Chairman and Chuck Grassley, Ranking Member. Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia. http://www.finance.senate.gov/newsroom/chairman/download/?id=9e4b091f-de21-4df1-b65e- b227d74bec12. January 2010. Accessed/link last verified August 15, 2014. Committee on Finance, United States Senate. Staff Report to the Chairman and Ranking Member. The Intimidation of Dr. John Buse and the Diabetes Drug Avandia. http://www.finance.senate.gov/download/?id=883E903D-F973-4A74-8432-3C651C71B4B4. November 2007. Accessed/link last verified August 15, 2014. Cowley AJ, Skene A, Stainer K, Hampton JR. The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. Int J Cardiol. 1993;40:161- 166. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004 Sep 16;351(12):1250-1251. Epub 2004 Sep 8. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. International Committee of Medical Journal Editors. Is this clinical trial fully registered?--A statement from the International Committee of Medical Journal Editors. N Engl J Med. 2005 Jun 9;352(23):2436-2438. Epub 2005 May 23. Department of Justice, Office of Public Affairs. GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data. 2012 Jul 2. http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud- allegations-and-failure-report. Accessed/link last verified December 13, 2014. Dickersin K, Chalmers I. Recognising, investigating and dealing with incomplete and biased reporting of clinical research: from Francis Bacon to the World Health Organisation. James Lind Library, 2010. (Available at: http://www.jameslindlibrary.org/illustrating/articles/recognising-investigating-and- dealing-with-incomplete-and-biase). Dickersin K. Publication bias: recognizing the problem, understanding its origins and scope, and preventing harm. In: Rothstein HR, Sutton AJ, and Borenstein M, eds. Publication Bias in Meta- Analysis: Prevention, Assessment and Adjustments. West Sussex, England: John Wiley & Sons; 2005:11-33. Djulbegovic B, Lacevic M, Cantor A, et al. The uncertainty principle and industry-sponsored research. Lancet 2000;356(9230):635-638. Doody RS, Raman R, Farlow M, et al. A phase 3 trial of semagacestat for treatment of Alzheimer’s disease. N Engl J Med. 2013 July 25;369(4):341-350. Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865. doi: 10.1136/bmj.f2865. Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Med. 2012;9(4): e1001201. doi: 10.1371/journal.pmed.1001201. Doshi P. Neuraminidase inhibitors: the story behind the Cochrane review. BMJ. 2009 Dec 12; 339:b5164. Doshi P. Putting GlaxoSmithKline to the test over paroxetine. BMJ. 2013;347:f6754. doi: 10.1136/bmj.f6754. Drazen JM, Morrissey S, Curfman GD. Rosiglitazone--continued uncertainty about safety. N Engl J Med. 2007 Jul 5;357(1):63-64. Epub 2007 Jun 5. Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011 Jan 19;(1):MR000031. doi: 10.1002/14651858.MR000031.pub2. Dwan K, Gamble C, Williamson PR, Kirkham JL, for the Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias – an updated review. PLoS ONE. July 2013;8(7): e66844,1-37. doi:10.1371/journal.pone.0066844 Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21;324(12):781-788. Editorial commentary. Dealing with biased reporting of the available evidence. 2007. The James Lind Library (www.jameslindlibrary.org). Editorial. The reporting of unsuccessful cases. Boston Medical and Surgical Journal. 1909;161:263- 264. Eikelboom JW, Connolly SJ, Brueckmann, M, Granger CB, Kappetein AP, Mack MJ, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sept 26;369(13):1206- 1214. European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use. October 2, 2014. www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf. Accessed/link last verified January 1, 2015. Evans I, Thornton H, Chalmers I, Glasziou P. Testing Treatments: Better Research for Better Healthcare. 2nd ed. London: Pinter & Martin Ltd, 2011. (Also available online: www.testingtreatments.org). FDA Amendments Act of 2007. http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW- 110publ85.pdf. [In particular, see pages 82 (http://www.gpo.gov/fdsys/pkg/PLAW- 110publ85/pdf/PLAW-110publ85.pdf#page=82), 91 (http://www.gpo.gov/fdsys/pkg/PLAW- 110publ85/pdf/PLAW-110publ85.pdf#page=91), and 98 (http://www.gpo.gov/fdsys/pkg/PLAW- 110publ85/pdf/PLAW-110publ85.pdf#page=98), with the areas referenced therein and pages between also being recommended.] FDAAA 801 requirements. ClinicalTrials.gov website. https://www.clinicaltrials.gov/ct2/manage- recs/fdaaa. Last reviewed December 2014. Accessed/link last verified December 19, 2014. Ferriar J. Medical Histories and Reflexions, vol 1. London: Cadell and Davies, 1792. (In particular, see the preface; available in full at https://play.google.com/books/reader?printsec=frontcover&output=reader&id=wG0FAAAAQAAJ&p g=GBS.PP7) Furberg CD. Effect of antiarrhythmic drugs on mortality after myocardial infarction. American Journal of Cardiology. 1983;52:32C-36C. Giel JL. Comparison of results reporting on ClinicalTrials.gov by funding source. Curr Med Res Opin. 2011;27(Suppl 1):S8. doi:10.1185/03007995.2011.564047 (only available in an abstract format due to it being from a presentation at the Annual Meeting of the International Society for Medical Publication Professionals). Godlee F, Clarke M. Why don’t we have all the evidence on oseltamivir? BMJ. 2009 Dec 12;339:b5351. Godlee F. One promise fulfilled, much still to be done. BMJ. 2015;350:g7811. doi: 10.1136/bmj.g7811. Godlee F. We want raw data, now. BMJ. 2009;339:b5405. Goldacre B. Are clinical trial data shared sufficiently today? No. BMJ. 2013;347:f1880. Goldkind L. Medical officer’s gastroenterology advisory committee briefing document. http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_05_gi.pdf. Accessed/link last verified August 24, 2011. Guyatt G, Rennie D, Meade MO, Cook DJ, eds. Users' guides to the medical literature: Essentials of evidence-based clinical practice. 2nd ed. American Medical Association, 2008. Harris G. Diabetes drug maker hid test data, files indicate. The New York Times. 2010 July 13. http://www.nytimes.com/2010/07/13/health/policy/13avandia.html. Accessed/link last verified December 13, 2014. (Avandia and its risks. http://documents.nytimes.com/avandia-and-its-risks. Accessed/link last verified December 13, 2014.
Load more

Recommended publications
  • Joint Statement on Public Disclosure of Results from Clinical Trials
    Joint statement on public disclosure of results from clinical trials Signatories on 18 May 2017 Indian Council of Medical Research Research Council of Norway UK Medical Research Council Médecins Sans Frontières Epicentre CEPI PATH Institut Pasteur Bill and Melinda Gates Foundation Wellcome Trust Introduction The current 2013 Declaration of Helsinki states that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” and that “Researchers have a duty to make publicly available the results of their research .... Negative and inconclusive as well as positive results must be published or otherwise made publicly available”. In addition to the ethical imperative, poor allocation of resources for product development and financing of available interventions, and suboptimal regulatory and public health recommendations may occur where decisions are based on only a subset of all completed clinical trials. The signatories of this joint statement affirm that the prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. Furthermore timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health. Within 12 months of becoming a signatory of this statement, we each pledge to develop and implement a policy with mandated timeframes for prospective registration and public disclosure of the results of clinical trials that we fund, co-fund, sponsor or support. We each agree to monitor registration and endorse the development of systems to monitor results reporting on an ongoing basis.
    [Show full text]
  • Transparency in the Time of Constant Change
    PhUSE 2014 Paper RG02 Transparency in the Time of Constant Change Todd Case, Biogen Idec, Cambridge MA, USA ABSTRACT The time has come, after years of hard work, to submit your application to the regulatory agency for review and possible approval! What a relief to be able to finally hand off all of your hard work and, wait a minute, ensure that all data can be reproducible?!? While CDISC has been widely adopted and its SDTM and AdAM models widely implemented, there is still the need to understand the process of ensuring that all the data is a reflection of how it was originally collected, which in some cases can be very challenging. This paper will discuss some more trending ways of both creating and presenting data in ways that ensure it is consumable and can be understood not only for analysis/submission purposes but also that post-approval it is transparent and that everyone who has a vested stake can review the data in an appropriate way. INTRODUCTION With the publication of Bad Pharma: How Medicine is Broken , and How We Can Fix it, by Dr. Ben Goldacre in 2013 a bright spotlight was shone on the data behind/supporting clinical trials. A large part of his thesis is that pharmaceutical companies exaggerate the efficacy of successful trials and that, in addition to drug companies, regulators , physicians (who are educated by the drug companies) and even patient groups have failed to protect us. Another rather striking revelation was that a clinical trial with positive results is twice more likely to be published than one with negative results (although it should be noted that this specifically is related to results – the protocol is always provided).
    [Show full text]
  • Patents, Partnerships, and the Pre-Competitive Collaboration Myth in Pharmaceutical Innovation
    Patents, Partnerships, and the Pre-Competitive Collaboration Myth in Pharmaceutical Innovation Liza S. Vertinsky* Public-private partnerships offer a promising alternative paradigm for pharmaceutical innovation in complex disease areas where there are both strong commercial interests and significant public need. They have the potential to reduce the tremendous waste associated with duplicative unsuccessful drug development efforts and to encourage the sharing of knowledge essential to accelerate pharmaceutical innovation. Patents threaten the potential of partnership strategies, however, by making it harder to sustain robust systems of knowledge sharing. Policymakers have tried to avoid this problem by focusing partnership strategies on areas deemed to be pre-competitive — areas of collaboration without competition and typically also without patents. This Article suggests that the current pre-competitive approach to partnership strategies in pharmaceutical innovation is fundamentally flawed for two reasons. First, it ignores the competitive market pressures that both shape what is deemed to be pre-competitive and fuel tensions * Copyright © 2015 Liza S. Vertinsky. Associate Professor of Law, Emory University School of Law. Many thanks to Timothy Holbrook, Timothy Terrell, Yaniv Heled, Cynthia Ho, Kevin Outterson, and Michael Carroll, as well as Sean O’Connor, Roger Ford, Dan Burk, Mark McKenna, and other participants of the Yale Innovation Beyond IP conference 2014; Arti Rai, Jerome Reichman, Katherine Strandburg, Brett Frischmann, Michael Madison, Peter Lee, Margaret Chon, Sonali Shah, and the other participants in the Medical Commons Workshop at NYU in May 2014 and the 2nd Thematic Conference on the Knowledge Commons at NYU in September 2014; participants in the summer workshop at Georgia State College of Law in July 2014; participants of the Emory Faculty Colloquium; Simon Stern, Abraham Drassinower, Margaret J.
    [Show full text]
  • Report on Transparency and Registration in Clinical Research In
    Transparency and Registration in Clinical Research in the Nordic Countries By the Nordic Trial Alliance Working Group on Transparency and Registration Transparency and Registration in Clinical Research in the Nordic Countries Nordic Trial Alliance NordForsk Stensberggata 25 NO-0170 Oslo www.nta.nordforsk.org Design: jnd.no Printed by: 07 Group ISSN 1504-8640 ER JØM KE IL T M 2 4 9 1 7 3 Trykksak Transparency and Registration in Clinical Research in the Nordic Countries By the Nordic Trial Alliance Working Group on Transparency and Registration 1 Table of Contents Preface 4 The Nordic Trial Alliance Working Group on Transparency and Registration 6 Conflicts of Interest 7 Abbreviations 8 1. Executive summary 16 2. Background 20 3. Introduction to transparency 30 4. International policies and regulations impacting the future of transparency 36 4.1 The Declaration of Helsinki 36 4.2 The Food and Drug Administration Amendments Act of 2007 36 4.3 The European Clinical Research Infrastructures Network (ECRIN) 37 4.4 European Medicines Agency 37 4.5 Horizon 2020 38 4.6 Regulation on clinical trials on medicinal product for human use 39 4.7 EU Regulation for data protection 40 5. Arguments in favour of and against transparency 44 5.1 Arguments in favour 44 5.2 Arguments against 49 6. Does publication of trial protocols or trial results in registers impede journal publications? 54 7. Registries and repositories 58 2 8. Status of the Nordic countries 62 8.1 Current national procedures for public, prospective registration and reporting of clinical
    [Show full text]
  • Histories of Medical Lobbying’
    ‘Histories of medical lobbying’ The lobbying of government ministers by medical professionals is a live issue. In Britain and around the world medical practitioners have become active in the pursuit of legislative change. In the UK, the AllTrials campaign co-founded by the physician-researcher Ben Goldacre continues to exert pressure on parliamentarians in a bid to force greater transparency in the publication of clinical trial results. Meanwhile, the California Medical Association advocates the legalisation of the recreational use of marijuana, and doctors in Australia refuse to release child refugees from hospital into detention centres damaging to their mental health. It was precisely the lobbying of medical humanitarians such as Médecins sans Frontières in France that effected a change in the law there in 1998, permitting undocumented immigrants with life-threatening conditions to remain in the country for medical treatment. Each of these examples represents an organised attempt on the part of medical professionals to change government policy on matters related to public health – in other words, lobbying. Yet a recent announcement by the UK cabinet office suggests that henceforth recipients of public funding will be banned from directly lobbying government ministers in the hope of changing public policy. When questioned in parliament David Cameron stated that charities should be devoting themselves to ‘good causes’ rather than ‘lobbying ministers’. Unless some qualification is forthcoming, medical researchers too will be proscribed from carrying out such activity. This insinuates that lobbying is in some way outside the proper remit of researchers, medical or otherwise. Yet even a cursory glance at the history of the medical profession’s engagement with public health reveals a longstanding and significant engagement with the political process.
    [Show full text]
  • SENSE ABOUT SCIENCE 14A Clerkenwell Green London EC1R 0DP T 020 7490 9590
    SENSE ABOUT SCIENCE 14A Clerkenwell Green London EC1R 0DP T 020 7490 9590 Registered Charity No. 1146170 Company No. 6771027 Registered in England and Wales Response to House of Commons Science and Technology Select Committee inquiry on research integrity 10th March 2017 Sense about Science is an independent charity that challenges the misrepresentation of science and scientific evidence in public life. We advocate for openness and honesty about research findings, and work to ensure the public interest in sound science and evidence is represented and recognised in public discussion and policy making. Sense about Science runs the AllTrials campaign which calls for all past and present clinical trials to be registered and their full methods and summary results reported. The AllTrials campaign is providing a separate submission for this inquiry. However there are two other areas under the terms of this inquiry that we would like to bring the committee’s attention. A single, publicly searchable database of all government-commissioned research In June 2015 Sense about Science began an inquiry into whether the government is reporting the policy research it commissions, following a spate of accusations of suppression of inconvenient results. Led by the former Appeal Court judge, Rt Hon Sir Stephen Sedley, its report Missing Evidence was published in June 2016.1 The inquiry revealed widespread confusion in the way research commissioned by government is handled, both internally and with the public: • There are significant differences in the way departments report and record research; • 11 government departments were unable to provide a list of research they have commissioned; • Of these, seven said that they did not hold that information centrally and it would be too costly to gather.
    [Show full text]
  • Improving Medicines for Children in Canada
    IMPROVING MEDICINES FOR CHILDREN IN CANADA The Expert Panel on Therapeutic Products for Infants, Children, and Youth Science Advice in the Public Interest IMPROVING MEDICINES FOR CHILDREN IN CANADA The Expert Panel on Therapeutic Products for Infants, Children, and Youth ii Improving Medicines for Children in Canada THE COUNCIL OF CANADIAN ACADEMIES 180 Elgin Street, Suite 1401, Ottawa, ON, Canada K2P 2K3 Notice: The project that is the subject of this report was undertaken with the approval of the Board of Governors of the Council of Canadian Academies (the Council). Board members are drawn from the Royal Society of Canada (RSC), the Canadian Academy of Engineering (CAE), and the Canadian Academy of Health Sciences (CAHS), as well as from the general public. The members of the expert panel responsible for the report were selected by the Council for their special competencies and with regard for appropriate balance. This report was prepared for the Government of Canada in response to a request from the Minister of Health. Any opinions, findings, or conclusions expressed in this publication are those of the authors, the Expert Panel on Therapeutic Products for Infants, Children, and Youth, and do not necessarily represent the views of their organizations of affiliation or employment. Library and Archives Canada Cataloguing in Publication Library and Archives Canada Cataloguing in Publication Improving medicines for children in Canada / The Expert Panel on Therapeutic Products for Infants, Children, and Youth. Issued also in French under title: Améliorer les médicaments pour enfants au Canada. Includes bibliographical references and index. Issued in print and electronic formats.
    [Show full text]
  • How Open Science Helps Researchers Succeed Abstract Open Access, Open Data, Open Source and Other Open Scholarship Practices Are Growing in Popularity and Necessity
    FEATURE ARTICLE POINT OF VIEW How open science helps researchers succeed Abstract Open access, open data, open source and other open scholarship practices are growing in popularity and necessity. However, widespread adoption of these practices has not yet been achieved. One reason is that researchers are uncertain about how sharing their work will affect their careers. We review literature demonstrating that open research is associated with increases in citations, media attention, potential collaborators, job opportunities and funding opportunities. These findings are evidence that open research practices bring significant benefits to researchers relative to more traditional closed practices. DOI: 10.7554/eLife.16800.001 ERIN C MCKIERNAN*, PHILIP E BOURNE, C TITUS BROWN, STUART BUCK, AMYE KENALL, JENNIFER LIN, DAMON MCDOUGALL, BRIAN A NOSEK, KARTHIK RAM, COURTNEY K SODERBERG, JEFFREY R SPIES, KAITLIN THANEY, ANDREW UPDEGROVE, KARA H WOO AND TAL YARKONI Introduction advantage to gain more citations, media atten- Recognition and adoption of open research tion, potential collaborators, job opportunities practices is growing, including new policies that and funding opportunities. We address common increase public access to the academic literature myths about open research, such as concerns (open access; Bjo¨rk et al., 2014; Swan et al., about the rigor of peer review at open access 2015) and encourage sharing of data (open journals, risks to funding and career advance- data; Heimsta¨dt et al., 2014; Michener, 2015; ment, and forfeiture of author rights. We recog- Stodden et al., 2013), and code (open nize the current pressures on researchers, and source; Stodden et al., 2013; Shamir et al., offer advice on how to practice open science 2013).
    [Show full text]
  • EU Regulation on Clinical Trials: Further Enhance Clinical Data Transparency
    TransAtlantic Consumer Dialogue Nordic Cochrane Centre Brussels, 11 October 2013 Joint letter to Member States’ Ministers of Health and Permanent Representatives (CoRePers) EU Regulation on clinical trials: further enhance clinical data transparency A clear stance by the Council in favour of freedom of information for European citizens and of public access to clinical trial data is needed. Selective publication of only those results which favour the drug in question biases scientific analysis, Medicines Agencies’ decisions and clinical decision making, therefore putting public health at risk and wasting resources of Member States’ healthcare systems (a). Moreover, it is an unethical practice contrary to the Helsinki Declaration and to the basic scientific and political principle of transparency, and it calls for a political answer (b). On 29 May 2013, the Environment, Public Health and Food Safety (ENVI) Committee adopted a perfectly reasonable demand in order to finally allow for independent analysis of clinical trials: that clinical data contained in clinical study reports (CSRs) "should not be considered commercially confidential once a marketing authorisation has been granted or the decision-making process on an application for marketing has been completed" (amendment 30, creating a new recital). This demand is in line with the European Medicines Agency policy on access to documents (1) and with the position of the European Ombudsman who found that clinical study reports (CSRs) do not contain commercially confidential information or personal data (participants’ clinical data are previously anonymised) (2). This was confirmed by an in-depth analysis of 78 clinical trials by two researchers from the Cochrane Collaboration in early 2013 (3) (c).
    [Show full text]
  • How Open Science Helps Researchers Succeed Erin Mckiernan National Autonomous University of Mexico
    University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Copyright, Fair Use, Scholarly Communication, etc. Libraries at University of Nebraska-Lincoln 7-7-2016 How open science helps researchers succeed Erin McKiernan National Autonomous University of Mexico Philip E. Bourne National Institutes of Health C. Titus Brown University of California, Davis Stuart Buck Laura and John Arnold Foundation Amye Kenall BioMed Central See next page for additional authors Follow this and additional works at: http://digitalcommons.unl.edu/scholcom Part of the Intellectual Property Law Commons, Scholarly Communication Commons, and the Scholarly Publishing Commons McKiernan, Erin; Bourne, Philip E.; Brown, C. Titus; Buck, Stuart; Kenall, Amye; Lin, Jennifer; McDougall, Damon; Nosek, Brian A.; Ram, Karthik; Soderberg, Courtney K.; Spies, Jeffrey R.; Thaney, Kaitlin; Updegrove, Andrew; Woo, Kara H.; and Yarkoni, Tal, "How open science helps researchers succeed" (2016). Copyright, Fair Use, Scholarly Communication, etc.. 24. http://digitalcommons.unl.edu/scholcom/24 This Article is brought to you for free and open access by the Libraries at University of Nebraska-Lincoln at DigitalCommons@University of Nebraska - Lincoln. It has been accepted for inclusion in Copyright, Fair Use, Scholarly Communication, etc. by an authorized administrator of DigitalCommons@University of Nebraska - Lincoln. Authors Erin McKiernan, Philip E. Bourne, C. Titus Brown, Stuart Buck, Amye Kenall, Jennifer Lin, Damon McDougall, Brian A. Nosek, Karthik Ram, Courtney K. Soderberg, Jeffrey R. Spies, Kaitlin Thaney, Andrew Updegrove, Kara H. Woo, and Tal Yarkoni This article is available at DigitalCommons@University of Nebraska - Lincoln: http://digitalcommons.unl.edu/scholcom/24 1 How open science helps researchers succeed 1 2 3 4 5 2 Erin C.
    [Show full text]
  • Head to Head BMJ: First Published As 10.1136/Bmj.F1880 on 9 July 2013
    BMJ 2013;347:f1880 doi: 10.1136/bmj.f1880 (Published 9 July 2013) Page 1 of 3 Head to Head BMJ: first published as 10.1136/bmj.f1880 on 9 July 2013. Downloaded from HEAD TO HEAD HEAD TO HEAD Are clinical trial data shared sufficiently today? No The AllTrials campaign asks for all trials to be registered and their results published. Ben Goldacre says we need the evidence to make informed decisions about medicines. John Castellani (doi:10. 1136/bmj.f1881) says mandatory disclosure could affect patient privacy, stifle discovery, and allow competitors or unscrupulous actors to use the information Ben Goldacre Wellcome research fellow in epidemiology London School of Hygiene and Tropical Medicine When discussing transparency it is important to be clear on what The arguments against this level of transparency are conflicted is being requested, as obfuscation is sometimes used to avoid and misguided. John Castellani, of the Pharmaceutical Research discussing simple fixes. At stake are four levels of information and Manufacturers of America (PhRMA), has claimed about trials: (1) knowledge that a trial has been conducted, from previously that it’s enough for regulators alone to see all the a clinical trials register; (2) a brief summary of a trial’s results, information on trials, and to see it behind closed doors. But this http://www.bmj.com/ in an academic journal article or regulatory summary; (3) longer goes against the fundamental principles of science: we rely on details about the trial’s methods and results, from a clinical transparency about methods and results, so that every experiment study report where available; (4) individual patient data.
    [Show full text]
  • Number of Nutritional Claims for Regulatory Action
    www.healthwatch-uk.org Established 1991 @HealthWatchUK HealthWatch Newsletter for Science and Integrity in Medicine Issue 105 Spring/Summer 2017 What is the impact of the US president’s belief that ‘Vaccines Cause Autism’? Andrew Wakefield’s1 infamous Lancet article proposed the combined Measles, Mumps and Rubella vaccine is a causal factor in autism. It was later retracted on grounds of ‘data distortion’ and Wakefield was struck off the medical register. Following the spread of Wakefield’s ‘vaccine autism meme’ (VAM), parental fear that vaccines cause autism is one underlying reason why some parents in the USA seek exemption from compulsory vaccination laws.2 Haberman3 traced the roots of an anti-vaccine movement in the USA to Wakefield’s article. Although some say ‘America sneezes and Britain catches a cold’ this story confirms two-way ‘cognitive contamination’. From the public health perspective high uptake of ‘Autism has become an epidemic. Twenty five years ago, vaccination is essential to provide a level of immunity at thirty five years ago, you look at the statistics, not even population level (sometimes known as ‘herd immunity’). close. It has gotten totally out of control. I am totally in Research has shown that parental knowledge, trust and favour of vaccines, but I want smaller doses over a longer information about vaccination relies, not only on health period of time. Because you take a baby in, and I’ve seen messages from health professionals, but also those from it, and I’ve seen it, and I had my children taken care of the media, who have become increasingly influential in over a long period of time, over a two or three year period decision making, hence increasing ‘vaccination hesitancy’.
    [Show full text]