Transparency Supplemental Reading List

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.

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

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

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

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.

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.

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.

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.

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.

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

Data Sharing

Taichman DB, et al. “Data sharing statements for clinical trials.” BMJ. 2017;357:j2372.

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

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.

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

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.

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.

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

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

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

Sunshine Act

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.

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.

 

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