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

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 Chan A. Out of sight but not out of mind: how to search for unpublished clinical trial evidence.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.

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