Transparency and credibility of industry-sponsored clinical trial publications: a survey of journal editors

References

• Kesselheim AS, Robertson CT, Myers JA, et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012;367(12):1119–1127.
   PubMed Web of Science ®Google Scholar
• McGauran N, Wieseler B, Kreis J, et al. Reporting bias in medical research – a narrative review. Trials. 2010;11:37.
   PubMed Web of Science ®Google Scholar
• Chalmers I, Glasziou P, Godlee F. All trials must be registered and the results published. BMJ. 2013;346:f105.
   PubMed Web of Science ®Google Scholar
• Alltrials.net. All trials registered. All results reported [Internet] [cited 2016 Nov 8]. Available from: http://www.alltrials.net/wp-content/uploads/2013/09/What-does-all-trials-registered-and-reported-mean.pdf
   Google Scholar
• De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351(12):1250–1251.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Food and Drug Administration Amendments Act of 2007 [Internet]. 2007 [cited 2016 November 8]. Available from: https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
   Google Scholar
• International Federation of Pharmaceutical Manufacturers and Associations. Joint Position on the Publication of Clinical Trial Results in the Scientific Literature [Internet]. 2010 [cited 8 Nov 2016]. Available from: http://www.efpia.eu/uploads/Modules/Documents/20100610_joint_position_publication_10jun2010.pdf
   Google Scholar
• Pfizer. Public Disclosure of Pfizer Clinical Study Data and Authorship [Internet]. 2014 [cited 2016 Nov 9]. Available from: http://www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship
   Google Scholar
• GlaxoSmithKline. Public Disclosure of Clinical Research [Internet]. 2014 [cited 9 Nov 2016]. Available from: https://www.gsk.com/en-gb/research/our-approach/sharing-our-research/
   Google Scholar
• Janssen. Clinical Data Transparency [Internet] [cited 2017 Apr 24]. Available from: http://www.janssen.com/us/clinical-data-transparency
   Google Scholar
• Amgen. Clinical Trial Transparency, Data Sharing and Disclosure Practices [Internet] [cited 2017 Apr 24]. Available from: http://www.amgen.com/about/how-we-operate/policies-practices-and-disclosures/ethical-research/clinical-data-transparency-practices/
   Google Scholar
• AstraZeneca. AstraZeneca Clinical Trials Website [Internet] [cited 2017 Apr 24]. Available from: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Search
   Google Scholar
• Biogen. Clinical Trial Transparency and Data Sharing [Internet] [cited 2017 Apr 24]. Available from: http://clinicalresearch.biogen.com/
   Google Scholar
• Bristol-Meyers Squibb. Disclosure Commitment [Internet] [cited 2017 Apr 24]. Available from: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
   Google Scholar
• Merck. Policies and Perspectives [Internet] [cited 2017 Apr 24]. Available from: http://www.merck.com/clinical-trials/policies-perspectives.html
   Google Scholar
• Takeda. Takeda Clinical Trials [Internet] [cited 2017 Apr 24]. Available from: https://www.takedaclinicaltrials.com/
   Google Scholar
• Mansi BA, Clark J, David FS, et al. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87(5):424–429.
   PubMed Web of Science ®Google Scholar
• Goldacre B, Lane S, Mahtani KR, et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. BMJ. 2017;358:j3334.
   PubMedGoogle Scholar
• Albert DM, Liesegang TJ, Schachat AP. Meeting our ethical obligations in medical publishing: responsibilities of editors, authors, and readers of peer-reviewed journals. Arch Ophthalmol. 2005;123(5):684–686.
   PubMedGoogle Scholar
• DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical science: the adverse effects of industry influence. JAMA. 2008;299(15):1833–1835.
   PubMed Web of Science ®Google Scholar
• Angell M. Industry-sponsored clinical research: a broken system. JAMA. 2008;300(9):1069–1071.
   PubMed Web of Science ®Google Scholar
• Eysenbach G. Improving the quality of web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res. 2004;6(3):e34.
   PubMed Web of Science ®Google Scholar
• ICMJE. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals [Internet] [cited 2018 Dec 21]. Available from: http://www.icmje.org/icmje-recommendations.pdf
   Google Scholar
• Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461–464.
   PubMed Web of Science ®Google Scholar
• Wager E, Fiack S, Graf C, et al. Science journal editors’ views on publication ethics: results of an international survey. J Med Ethics. 2009;35(6):348–353.
   PubMed Web of Science ®Google Scholar
• Hopewell S, Altman DG, Moher D, et al. Endorsement of the CONSORT statement by high impact factor medical journals: a survey of journal editors and journal ‘Instructions to Authors’. Trials. 2008;9:20.
   PubMed Web of Science ®Google Scholar
• Fuller T, Pearson M, Peters J, et al. What affects authors’ and editors’ use of reporting guidelines? Findings from an online survey and qualitative interviews. PloS One. 2015;10(4):e0121585.
   PubMed Web of Science ®Google Scholar
• Hooft L, Korevaar DA, Molenaar N, et al. Endorsement of ICMJE’s Clinical Trial Registration Policy: a survey among journal editors. Netherlands J Med. 2014;72(7):349–355.
   PubMed Web of Science ®Google Scholar
• Self CC. Credibility. In: Salwen MB, Stacks DW, editors. An integrated approach to communication theory and Research. Mahway (IL).: Lawrence Erlbaum; 1996. p. 421–441.
   Google Scholar
• Hilligoss B, Rieh SY. Developing a unifying framework of credibility assessment: construct, heuristics, and interaction in context. Inf Proc Manage. 2008;44:1467–1484.
   Web of Science ®Google Scholar
• Gopal AD, Wallach JD, Aminawung JA, et al. Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals. Trials. 2018;19(1):448.
   PubMedGoogle Scholar
• Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open. 2015;5(11):e009758.
   PubMed Web of Science ®Google Scholar
• Miller JE, Wilenzick M, Ritcey N, et al. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open. 2017;7(12):e017917.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use [Internet]. 2014 [cited 2017 Mar 13]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Dunn AG, Coiera E, Mandl KD, et al. Conflict of interest disclosure in biomedical research: a review of current practices, biases, and the role of public registries in improving transparency. Res Integ Peer Rev. 2016;1:1–8.
   PubMedGoogle Scholar
• Cannon MF. How To Minimize Conflicts of Interest in Medical Research [Internet]. 2016 [cited 2017 Mar 23]. Available from: https://www.forbes.com/sites/michaelcannon/2016/04/04/how-to-minimize-conflicts-of-interest-in-medical-research/#3d527515398d
   Google Scholar
• Ornstein C, Thomas K. Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals: ProPublica [Internet]. 2018 [cited 2018 Dec 10]. Available from: https://www.propublica.org/article/doctor-jose-baselga-cancer-researcher-corporate-financial-ties
   Google Scholar
• Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. Ann Intern Med. 2017;167(1):63–65.
   PubMed Web of Science ®Google Scholar
• GlaxoSmithKline. Clinical Study Register [Internet] [cited 14 Mar 2017]. Available from: http://www.gsk.com/en-gb/research/sharing-our-research/clinical-study-register/
   Google Scholar
• Pfizer. Trial Data & Results [Internet] [cited 2017 Mar 14]. Available from: http://www.pfizer.com/research/clinical_trials/trial_data_and_results
   Google Scholar
• CSDR. Clinical Study Data Request [Internet] [cited 2017 Mar 14]. Available from: https://clinicalstudydatarequest.com/Default.aspx
   Google Scholar
• Center for Outcomes Research and Evaluation, Yale University. The Yoda Project [Internet] [cited 2017 Mar 14]. Available from: http://yoda.yale.edu/
   Google Scholar
• Duke Clinical Research Institute. Open Science [Internet] [cited 2017 Mar 14]. Available from: http://www.dcri.org/insights/open-science/
   Google Scholar
• Clinicaltrials.gov [Internet] [cited 2018 Dec 11]. Available from: https://clinicaltrials.gov/ct2/manage-recs/fdaaa
   Google Scholar
• Marusic A, Hren D, Mansi B, et al. Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications. BMC Med. 2014;12:197.
   PubMed Web of Science ®Google Scholar
• Chipperfield L, Citrome L, Clark J, et al. Authors’ Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin. 2010;26(8):1967–1982.
   PubMed Web of Science ®Google Scholar
• Lineberry N, Berlin JA, Mansi B, et al. Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ. 2016;355:i5078.
   PubMedGoogle Scholar
• European Medicines Agency. Trial protocols: modalities and timing of posting [Internet] [cited 2017 Apr 24]. Available from: https://eudract.ema.europa.eu/docs/guidance/Trial%20protocols_Modalities%20and%20timing%20of%20posting.pdf
   Google Scholar
• Department of Health and Human Services. Clinical Trials Registration and Results Information Submission; Final Rule. 42 CFR Part 11 [Internet]. Effective 2017 Jan 18 [cited 2017 Jun 6]. Available from: https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission
   Google Scholar
• International Federation of Pharmaceutical Manufacturers and Associations. Consensus framework for ethical collaboration [Internet] [cited 2017 Apr 24]. Available from: http://www.ifpma.org/subtopics/consensus-framework-for-ethical-collaboration/?parentid=264
   Google Scholar
• Evoniuk G, Mansi B, DeCastro B, et al. Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies. BMJ. 2017;357:j1726.
   PubMed Web of Science ®Google Scholar
• Mooney LA, Fay L. Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history. BMJ Open. 2016;6(7):e012362.
   PubMed Web of Science ®Google Scholar
• DeVito NJ, French L, Goldacre B. Noncommercial funders’ policies on trial registration, access to summary results, and individual patient data availability. JAMA. 2018;319(16):1721–1723.
   PubMed Web of Science ®Google Scholar
• Medical Publishing Insights & Practices. MPIP Transparency Matters [Internet] [cited 2017 Jun 5]. Available from: https://www.mpip-initiative.org/transparencymatters/index.html
   Google Scholar