Clinical Trial Data Sharing: What Do We Do Now?
Authors: Steven N. Goodman
Journal: Annals of Internal Medicine (2015)

Ideas and Opinions17 February 2015Clinical Trial Data Sharing: What Do We Do Now?Steven N. Goodman, MD, MHS, PhDSteven N. Goodman, MD, MHS, PhDFrom Stanford University, Stanford, California.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-0021 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Looking troubled amidst the hubbub of a successful election night, Robert Redford's title character in the 1972 movie The Candidate asks, “What do we do now?” We must ask the same question about clinical trial data sharing. Although the campaign for such sharing has effectively been won—with support expressed by government agencies, funders, research groups, journals, patient groups, and industry—data sharing is hardly routine (1). Maximizing its benefits and minimizing its risks remain a technical, procedural, and political challenge. This motivated the formation of the Institute of Medicine committee on Strategies for Responsible Sharing of Clinical Trial Data to outline ...References1. Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, et al. Sharing of clinical trial data among trialists: a cross sectional survey. BMJ. 2012;345:e7570. [PMID: 23169870] doi:10.1136/bmj.e7570 CrossrefMedlineGoogle Scholar2. Rosenblatt M, Jain SH, Cahill M. Sharing of clinical trial data: benefits, risks, and uniform principles. Ann Intern Med. 2015;162:306-7. doi:10.7326/M14-1299 LinkGoogle Scholar3. Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Pr; 2015. Google Scholar4. Gordon D, Taddei-Peters W, Mascette A, Antman M, Kaufmann PG, Lauer MS. Publication of trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med. 2013;369:1926-34. [PMID: 24224625] doi:10.1056/NEJMsa1300237 CrossrefMedlineGoogle Scholar5. 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Willingness to share research data is related to the strength of the evidence and the quality of reporting of statistical results. PLoS One. 2011;6:e26828. [PMID: 22073203] doi:10.1371/journal.pone.0026828 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Steven N. Goodman, MD, MHS, PhDAffiliations: From Stanford University, Stanford, California.Acknowledgment: Dr. Goodman is a member of the committee that wrote the Institute of Medicine report.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0021.Corresponding Author: Steven N. Goodman, MD, MHS, PhD, Stanford University, 259 Campus Drive, HRP/Redwood Building T265, Stanford, CA 94305; e-mail, steve.[email protected]edu.Author Contributions: Conception and design: S.N. Goodman.Drafting of the article: S.N. Goodman.Critical revision of the article for important intellectual content: S.N. Goodman.Final approval of the article: S.N. Goodman.This article was published online first at www.annals.org on 27 January 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoSharing of Clinical Trial Data: Benefits, Risks, and Uniform Principles Michael Rosenblatt , Sachin H. Jain , and Matthew Cahill Sharing of Clinical Trial Data: Benefits, Risks, and Uniform Principles Michael Rosenblatt , Sachin H. Jain , and Matthew Cahill Metrics Cited byGenomic Research Data Generation, Analysis and Sharing – Challenges in the African SettingLa generación Y ante el desafío de su inserción laboral: realidades frente a estereotiposPrecision medicine in cardiologySharing data from MS clinical trials: Opportunities, challenges, and future directionsA transparent future for clinical trial reporting 17 February 2015Volume 162, Issue 4Page: 308-309KeywordsClinical trial reportingClinical trialsData managementForecastingInformation storage and retrievalMotivationRisk managementStatistical dataTreatment guidelinesVision ePublished: 17 February 2015 Issue Published: 17 February 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...