Sharing of Clinical Trial Data: Benefits, Risks, and Uniform Principles
Authors: Michael Rosenblatt, Sachin H. Jain, Matthew Cahill
Journal: Annals of Internal Medicine (2015)

Ideas and Opinions17 February 2015Sharing of Clinical Trial Data: Benefits, Risks, and Uniform PrinciplesMichael Rosenblatt, MD, Sachin H. Jain, MD, and Matthew Cahill, BAMichael Rosenblatt, MDFrom Merck & Co., Kenilworth, New Jersey., Sachin H. Jain, MDFrom Merck & Co., Kenilworth, New Jersey., and Matthew Cahill, BAFrom Merck & Co., Kenilworth, New Jersey.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M14-1299 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Transparency and sharing of information from clinical trials have developed swiftly during the past 2 years. That pace has continued in 2014 with the European Medicines Agency's decision to share some of the information that it receives as part of the approval process for a new medicine (1), the implementation of principles on data-sharing by major pharmaceutical companies (2), and the release of the Institute of Medicine's consensus study (3). Much of the discussion in medical journals has focused on the pharmaceutical industry sharing data with investigators funded by academia or the government (4). As persons with careers in academic ...References1. Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency—sharing of clinical trial data. N Engl J Med. 2014;371:2452-5. [PMID: 25539105] doi:10.1056/NEJMp1409464 CrossrefMedlineGoogle Scholar2. Pharmaceutical Research and Manufacturers of America; European Federation of Pharmaceutical Industries and Associations. Principles for Responsible Clinical Trial Data Sharing. 18 July 2013. Accessed at www.phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf on 1 January 2015. Google Scholar3. Institute of Medicine. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC: National Academies Pr; 2014. Accessed at www.iom.edu/Activities/Research/SharingClinicalTrialData.aspx on 1 January 2015. Google Scholar4. Doshi P, Goodman SN, Ioannidis JP. Raw data from clinical trials: within reach? Trends Pharmacol Sci. 2013;34:645-7. [PMID: 24295825] doi:10.1016/j.tips.2013.10.006 CrossrefMedlineGoogle Scholar5. National Institutes of Health. NIH Data Sharing Policy. Bethesda, MD: National Institutes of Health; 2007. Accessed at http://grants.nih.gov/grants/policy/data_sharing on 1 January 2015. Google Scholar6. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373. [PMID: 22214756] doi:10.1136/bmj.d7373 CrossrefMedlineGoogle Scholar7. Cohen D. Rosiglitazone: what went wrong? BMJ. 2010;341:c4848. [PMID: 20819889] doi:10.1136/bmj.c4848 CrossrefMedlineGoogle Scholar8. Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ. 2013;347:f6123. [PMID: 24149819] doi:10.1136/bmj.f6123 CrossrefMedlineGoogle Scholar9. Hiatt WR, Kaul S, Smith RJ. The cardiovascular safety of diabetes drugs—insights from the rosiglitazone experience. N Engl J Med. 2013;369:1285-7. [PMID: 23992603] doi:10.1056/NEJMp1309610 CrossrefMedlineGoogle Scholar10. Godlee F. Adverse effects of statins [Editorial]. BMJ. 2014;348:g3306. [PMID: 25134141] doi:10.1136/bmj.g3306 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Michael Rosenblatt, MD; Sachin H. Jain, MD; Matthew Cahill, BAAffiliations: From Merck & Co., Kenilworth, New Jersey.Acknowledgment: The authors thank Christopher Lines from Merck & Co. for assistance in the preparation of this article.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1299.Corresponding Author: Michael Rosenblatt, MD, Merck & Co., K1-4118B, 2000 Galloping Hill Road, Kenilworth, NJ 07033; e-mail, [email protected].Current Author Addresses: Dr. Rosenblatt: Merck & Co., K1-4118B, 2000 Galloping Hill Road, Kenilworth, NJ 07033.Dr. Jain: CareMore, 12900 Park Plaza Drive, Cerritos, CA 90703.Mr. Cahill: Merck & Co., 351 North Sumneytown Pike, North Wales, PA 19454.Author Contributions: Conception and design: M. Rosenblatt, S.H. Jain, M. Cahill.Analysis and interpretation of the data: M. Rosenblatt, M. Cahill.Drafting of the article: M. Rosenblatt, M. Cahill.Critical revision of the article for important intellectual content: M. Rosenblatt, S.H. Jain, M. Cahill.Final approval of the article: M. Rosenblatt, S.H. Jain, M. Cahill.Administrative, technical, or logistic support: S.H. Jain.Collection and assembly of data: M. Rosenblatt, M. Cahill.This article was published online first at www.annals.org on 27 January 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoClinical Trial Data Sharing: What Do We Do Now? Steven N. Goodman Clinical Trial Data Sharing: What Do We Do Now? Steven N. 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Goodman, MD, MHS, PhD 17 February 2015Volume 162, Issue 4Page: 306-307KeywordsAcademic medicineClinical trialsDisclosureHuman sexual behaviorInternetPrevention, policy, and public healthRacial and ethnic issuesSafetyStatinsVaccines ePublished: 17 February 2015 Issue Published: 17 February 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...