Data Sharing Statements for Clinical Trials: One Step Down the Road
Authors: Darren B. Taichman, Christine Laine
Journal: Annals of Internal Medicine (2018)

Editorials16 October 2018Data Sharing Statements for Clinical Trials: One Step Down the RoadDarren B. Taichman, MD, PhD and Christine Laine, MD, MPHDarren B. Taichman, MD, PhDExecutive Editor, Annals of Internal Medicine; American College of Physicians, Philadelphia, Pennsylvania (D.B.T.)Search for more papers by this author and Christine Laine, MD, MPHEditor in Chief, Annals of Internal Medicine; American College of Physicians, Philadelphia, Pennsylvania (C.L.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-1704 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Suppose that the efforts of a clinical trial's participants, coordinators, investigators, and sponsors have resulted in a robust data set with the potential to inform the care of patients with a highly morbid condition. Five years later, what will the medical community have learned from these data? What will these data have changed about how we treat this condition? What in patients' lives will the data have helped to improve?If the answer to each of these questions is “nothing,” everyone will be disappointed. Yet, the effort to collect these data will have been a waste only if the answer ...References1. Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Pr; 2015. Google Scholar2. European Medicines Agency. Clinical data publication. 2018. Accessed at www.ema.europa.eu/ema/?curl=pages/special_topics/general/general_content_000555.jsp on 20 June 2018. Google Scholar3. National Institutes of Health. NIH data sharing policy. Updated 17 April 2007. Accessed at https://grants.nih.gov/grants/policy/data_sharing on 20 June 2018. Google Scholar4. U.S. Food and Drug Administration. Clinical data summary pilot program. Updated 3 May 2018. Accessed at www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm589210.htm on 20 June 2018. Google Scholar5. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors [Editorial]. Ann Intern Med. 2016;164:505-6. [PMID: 26792258]. doi:10.7326/M15-2928 LinkGoogle Scholar6. Wilkinson MD, Dumontier M, Aalbersberg IJ, Appleton G, Axton M, Baak A, et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data. 2016;3:160018. [PMID: 26978244] doi:10.1038/sdata.2016.18 CrossrefMedlineGoogle Scholar7. Tannenbaum S, Ross JS, Krumholz HM, Desai NR, Ritchie JD, Lehman R, et al. Early experiences with journal data sharing policies: a survey of published clinical trial investigators. Ann Intern Med. 2018;169:586-8. doi:10.7326/M18-0723 LinkGoogle Scholar8. Laine C, Goodman SN, Griswold ME, Sox HC. Reproducible research: moving toward research the public can really trust. Ann Intern Med. 2007;146:450-3. [PMID: 17339612] LinkGoogle Scholar9. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors [Editorial]. Ann Intern Med. 2017;167:63-5. [PMID: 28586790]. doi:10.7326/M17-1028 LinkGoogle Scholar10. Jones CW, Roberts BW, Platts-Mills TF. Patient perspectives on sharing deidentified trial data [Letter]. Ann Intern Med. 2016;165:748-9. [PMID: 27842399]. doi:10.7326/L16-0089 LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Executive Editor, Annals of Internal Medicine; American College of Physicians, Philadelphia, Pennsylvania (D.B.T.)Editor in Chief, Annals of Internal Medicine; American College of Physicians, Philadelphia, Pennsylvania (C.L.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-1704.This article was published at Annals.org on 17 July 2018. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEarly Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial Investigators Sara Tannenbaum , Joseph S. Ross , Harlan M. Krumholz , Nihar R. Desai , Jessica D. Ritchie , Richard Lehman , Ginger M. Gamble , Jacqueline Bachand , Sara Schroter , Trish Groves , and Cary P. Gross Metrics Cited byData Sharing Enters a New EraHoward Bauchner, MD, Mary M. McDermott, MD, and Atul J. Butte, MD, PhD 16 October 2018Volume 169, Issue 8Page: 581-582KeywordsAdverse eventsClinical trial reportingClinical trialsDisclosureInformation storage and retrievalMotivationPatientsStatistical data ePublished: 17 July 2018 Issue Published: 16 October 2018 Copyright & PermissionsCopyright © 2018 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...