Early Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial Investigators

Letters16 October 2018Early Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial InvestigatorsSara Tannenbaum, BA, Joseph S. Ross, MD, MHS, Harlan M. Krumholz, MD, SM, Nihar R. Desai, MD, MPH, Jessica D. Ritchie, MPH, Richard Lehman, MA, BM BCh, Ginger M. Gamble, MPH, Jacqueline Bachand, MPH, Sara Schroter, PhD, Trish Groves, MBBS, and Cary P. Gross, MDSara Tannenbaum, BAYale University School of Medicine, New Haven, Connecticut (S.T.), Joseph S. Ross, MD, MHSCenter for Outcomes Research and Evaluation, Yale–New Haven Hospital, Yale University School of Medicine, and Yale School of Public Health, New Haven, Connecticut (J.S.R., H.M.K.), Harlan M. Krumholz, MD, SMCenter for Outcomes Research and Evaluation, Yale–New Haven Hospital, Yale University School of Medicine, and Yale School of Public Health, New Haven, Connecticut (J.S.R., H.M.K.), Nihar R. Desai, MD, MPHCenter for Outcomes Research and Evaluation, Yale–New Haven Hospital, and Yale University School of Medicine, New Haven, Connecticut (N.R.D.), Jessica D. Ritchie, MPHCenter for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut (J.D.R., G.M.G.), Richard Lehman, MA, BM BChInstitute of Applied Health Sciences, University of Birmingham, Birmingham, United Kingdom (R.L.), Ginger M. Gamble, MPHCenter for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut (J.D.R., G.M.G.), Jacqueline Bachand, MPHYale School of Public Health, New Haven, Connecticut (J.B.), Sara Schroter, PhDThe BMJ, London, United Kingdom (S.S., T.G.), Trish Groves, MBBSThe BMJ, London, United Kingdom (S.S., T.G.), and Cary P. Gross, MDYale University School of Medicine, Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, and Yale Cancer Center, New Haven, Connecticut (C.P.G.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-0723 Annals Author Insight Video - Sara Tannenbaum, BA In this video, Sara Tannenbaum, BA, offers additional insight into the article, "Early Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial Investigators." SectionsSupplemental MaterialAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: An increasing number of professional, commercial, and governmental organizations advocate sharing clinical trial data in order to maximize the societal benefit from clinical research. Several journals with high impact factors have recently enacted data sharing policies that require trial authors to share clinical trial data or publish a data sharing statement (1–3). However, many have raised concerns about these new policies (4).Objective: To assess the opinions and experiences of authors who have committed to sharing clinical trial data.Methods: We asked authors of trials published between 1 January 2012 and 1 March 2016 in 3 high-impact journals that ...References1. Groves T. Sharing the raw data from medical research [corrected] [Editorial]. BMJ. 2009;338:b1252. [PMID: 19321550] doi:10.1136/bmj.b1252 CrossrefMedlineGoogle Scholar2. Barbui C. Sharing all types of clinical data and harmonizing journal standards [Editorial]. BMC Med. 2016;14:63. [PMID: 27038634] doi:10.1186/s12916-016-0612-8 CrossrefMedlineGoogle Scholar3. 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 Scholar4. Kalager M, Adami HO, Bretthauer M. Recognizing data generation [Letter]. N Engl J Med. 2016;374:1898. [PMID: 27096437] doi:10.1056/NEJMc1603789 CrossrefMedlineGoogle 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 Scholar Author, Article, and Disclosure InformationAffiliations: Yale University School of Medicine, New Haven, Connecticut (S.T.)Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, Yale University School of Medicine, and Yale School of Public Health, New Haven, Connecticut (J.S.R., H.M.K.)Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, and Yale University School of Medicine, New Haven, Connecticut (N.R.D.)Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut (J.D.R., G.M.G.)Institute of Applied Health Sciences, University of Birmingham, Birmingham, United Kingdom (R.L.)Yale School of Public Health, New Haven, Connecticut (J.B.)The BMJ, London, United Kingdom (S.S., T.G.)Yale University School of Medicine, Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, and Yale Cancer Center, New Haven, Connecticut (C.P.G.)See also: Editorial comment (page 581).Disclaimer: This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.Financial Support: By the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award 5T35DK104689-02.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-0723.Reproducible Research Statement: Study protocol: Available from Dr. Gross (e-mail, cary.[email protected]edu). Statistical code: Not applicable. Data set: Deidentified data set available from Dr. Gross (e-mail, cary.[email protected]edu).This article was published at Annals.org on 17 July 2018. PreviousarticleNextarticle Advertisement Annals Author Insight Video - Sara Tannenbaum, BA In this video, Sara Tannenbaum, BA, offers additional insight into the article, "Early Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial Investigators." FiguresReferencesRelatedDetailsSee AlsoData Sharing Statements for Clinical Trials: One Step Down the Road Darren B. Taichman and Christine Laine Metrics Cited byData-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment ReportsIntent to share Annals of Internal Medicine's trial data was not associated with data re-useStatus, use and impact of sharing individual participant data from clinical trials: a scoping reviewResearch on peer review and biomedical publicationInformationIncrease value and reduce waste in research on psychological therapiesData Sharing Statements for Clinical Trials: One Step Down the RoadDarren B. Taichman, MD, PhD and Christine Laine, MD, MPH 16 October 2018Volume 169, Issue 8Page: 586-588KeywordsClinical trialsDisclosureInterquartile rangePredictive modelingRenal diseases ePublished: 17 July 2018 Issue Published: 16 October 2018 Copyright & PermissionsCopyright © 2018 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...