Transparency Supplemental Reading List

View articles on key topics relevant to transparency in the publication of industry-sponsored research.

Predatory Journals and Congresses

Baum E. Beware the imposter: predatory conferences lure the unsuspecting. The MAP Newsletter: News and Trends. September 28, 2017.
The International Society for Medical Publication Professionals Web site.

Cress PE. Are predatory conferences the dark side of the open access movement? Aesthet Surg J. 2017;37(6):734-738. doi: 10.1093/asj/sjw247.

Hunziker R. Avoiding predatory publishers in the post-Beall world: tips for writers and editors. AMWA Journal. 2017;32(3):113-115.

Mercier E, et al. Invitations received from potential predatory publishers and fraudulent conferences: a 12-month early-career researcher experience.
Postgrad Med J. 2017 Sep 14. pii: postgradmedj-2017-135097. doi: 10.1136/postgradmedj-2017-135097. [Epub ahead of print].

Memon AR. Predatory journals spamming for publications: what should researchers do? Sci Eng Ethics. 2017 Aug 16. doi: 10.1007/s11948-017-9955-6. [Epub ahead of print].

Moher D, et al. Stop this waste of people, animals and money. Nature. 2017;549(7670):23-25. doi: 10.1038/549023a .
https://www.ncbi.nlm.nih.gov/pubmed/?term=28880300

Pearson GS. Avoiding predatory journals with “Think. Check. Submit.”
J Am Psychiatr Nurses Assoc. 2017;23(4):239-240. doi: 10.1177/1078390317716883.

Publication Best Practices

Battisti WP, et al. “Good publication practice for communicating company-sponsored medical research: GPP3.” Ann Intern Med. 2015;163(6):461-464.

Scott-Lichter D and the Editorial Policy Committee, Council of Science Editors.
“CSE’s White Paper on Promoting Integrity in Scientific Journal Publications, 2012 Update.” 3rd Revised Edition. Wheat Ridge, CO: 2012.

Consolidated Standards of Reporting Trials (CONSORT). “The CONSORT Flow Diagram.” CONSORT website.

International Committee of Medical Journal Editors (ICMJE). “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.” ICMJE website.

Data Reporting

Saito H, Gill CJ. “How frequently do the results from completed US clinical trials enter the public domain? - A statistical analysis of the ClinicalTrials.gov database.” PLoS One. 2014;9(7):e101826.

Dwan K, et al. Reporting Bias Group. “Systematic review of the empirical evidence of study publication bias and outcome reporting bias — an updated review.” PLoS One. 2013;8(7):e66844.

Jones CW, et al. “Non-publication of large randomized clinical trials: cross sectional analysis.” BMJ. 2013;347:f6104.

Transparency in Industry-Sponsored Research

Evoniuk G, 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.

Lassman SM, et al. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States. BMJ Open. 2017 Sep 23;7(9):e015110. doi: 10.1136/bmjopen-2016-015110.

Iliff SA, Savastano G. “Naked transparency in communication.” Lab Anim (NY). 2016;45(4):138.

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.

Weigel A. “Medical literature has seen a positive evolution of transparency.” BMJ. 2016;354:i5043.

DeTora L, et al. “Publication planning: promoting an ethics of transparency and integrity in biomedical research.” Int J Clin Pract. 2015;69(9):915-921.

Miller JE, et al. “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.

Pignatti F, et al. “Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future directions.” Clin Pharmacol Ther. 2015;98(5):522-533.

Alemayehu D, et al. “Perspectives on clinical trial data transparency and disclosure.” Contemp Clin Trials. 2014;39(1):28-33.

Data Sharing

Bierer B, et al. “Data authorship as an incentive to data sharing.” N Engl J Med. 2017;376(17):1684-1687.

Goldacre B, et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. BMJ. 2017;358: j3334. doi: 10.1136/bmj.j3334.

Taichman DB, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. N Engl J Med. 2017;376(23):2277-2279. doi: 10.1056/NEJMe1705439.

*Published simultaneously in BMJ, PLoS Med, Ann Intern Med, JAMA, Lancet, N Z Med J, Bull World Health Organ, Natl Med J India, J Korean Med Sci.

Hollis S, et al. “Best practice for analysis of shared clinical trial data.” BMC Med Res Methodol. 2016;16(suppl 1):76.

International Committee of Medical Journal Editors (ICMJE). “Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors.” Ann Intern Med. 2016;164(7):505-506.

Krumholz HM, Waldstreicher J. “The Yale Open Data Access (YODA) project — a mechanism for data sharing.” N Engl J Med. 2016;375(5):403-405.

Manamley N, et al. “Data sharing and the evolving role of statisticians.” BMC Med Res Methodol. 2016;16(suppl 1):75.

Mospan GA, Wargo KA. “Researchers’ experience with clinical data sharing.” J Am Board Fam Med. 2016;29(6):805-807.

Tucker K, et al. “Protecting patient privacy when sharing patient-level data from clinical trial.” BMC Med Res Methodol. 2016;16(suppl 1):77.

Hughes S, et al. “Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach.” Pharm Stat. 2014;13(3):179-183.

Fletcher C. “European Federation of Statisticians in the Pharmaceutical Industry’s position on access to clinical trial data.”
Pharm Stat. 2013;12(6):333-336.

Nisen P, Rockhold F. “Access to patient-level data from GlaxoSmithKline clinical trials.” N Engl J Med. 2013;369(5):475-478.

Conflicts of Interest

The May 2, 2017, issue of JAMA (volume 317, number 17, pages 1707-1812) is dedicated to conflicts of interest viewpoints and research articles. http://jamanetwork.com/journals/jama/issue/317/17. Several are highlighted below.

Mandrioli D, et al. Relationship between research outcomes and risk of bias, study sponsorship, and author financial conflicts of interest in reviews of the effects of artificially sweetened beverages on weight outcomes: a systematic review of reviews. PLoS One. 2016;11(9):e0162198. doi: 10.1371/journal.pone.0162198.

Cappola AR, FitzGerald GA. “Confluence, not conflict of interest. Name change necessary.” JAMA. 2015;314(17):1791-1792.

Lockhart AC, et al. “Physician and stakeholder perceptions of conflict of interest policies in oncology.” J Clin Oncol. 2013;31(13):1677-1682.

International Committee of Medical Journal Editors (ICMJE). “ICMJE Form for Disclosure of Potential Conflicts of Interest.” ICMJE website.

International Committee of Medical Journal Editors (ICMJE). “Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals.” ICMJE website.

Pharmaceutical Research and Manufacturers of America (PhRMA). “PhRMA principles on conduct of clinical trials.” PhRMA website.

Sunshine Act

Toroser D, et al. “Systematic review of reports describing potential impact of the Sunshine Act on peer-reviewed medical publications.” Curr Med Res Opin. 2016;32(3):547-553.

Toroser D, Pepitone K. “Two years into the Sunshine Act: synopsis of opportunities, challenges, learnings, and potential implications.” Curr Med Res Opin. 2016;32(11):1899-1902.

 

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