Data Escrow and Clinical Trial Transparency
Authors: Harlan M. Krumholz, Jeanie Kim
Journal: Annals of Internal Medicine (2017)

Ideas and Opinions20 June 2017Data Escrow and Clinical Trial TransparencyHarlan M. Krumholz, MD, SM and Jeanie Kim, JDHarlan M. Krumholz, MD, SMFrom Yale School of Medicine; Yale School of Public Health; Center for Outcomes Research and Evaluation, Yale New Haven Health; Yale Law School; and the Collaboration for Research Integrity and Transparency, New Haven, Connecticut.Search for more papers by this author and Jeanie Kim, JDFrom Yale School of Medicine; Yale School of Public Health; Center for Outcomes Research and Evaluation, Yale New Haven Health; Yale Law School; and the Collaboration for Research Integrity and Transparency, New Haven, Connecticut.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-0743 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In 2016, the International Committee of Medical Journal Editors (ICMJE) asked for public comments on a proposal to require trial investigators to share patient-level data within 6 months of publication (1). This proposal elicited a substantial array of opinions about the policy's appropriateness (2). The ICMJE has yet to make a final decision.Even if the policy is approved, key questions remain concerning its practical implementation, particularly surrounding how editors might ensure that authors share their data 6 months after publication. A related issue is how the public can be sure that the released data are the same as those ...References1. 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 Scholar2. Comments on the ICMJE's proposals for sharing clinical trial data. Accessed at https://forms.acponline.org/icmje-comments on 29 March 2017. Google Scholar3. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Editorial]. Ann Intern Med. 2004;141:477-8. [PMID: 15355883] LinkGoogle Scholar4. Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on trial registration 11 years after the ICMJE policy was established. N Engl J Med. 2017;376:383-391. [PMID: 28121511] doi:10.1056/NEJMsr1601330 CrossrefMedlineGoogle Scholar5. Surette EC. Volume 30A: Escrows. C.J.S. § 1 (2016). Google Scholar Author, Article, and Disclosure InformationAffiliations: From Yale School of Medicine; Yale School of Public Health; Center for Outcomes Research and Evaluation, Yale New Haven Health; Yale Law School; and the Collaboration for Research Integrity and Transparency, New Haven, Connecticut.Disclaimer: Ms. Kim is funded by the Laura and John Arnold Foundation through a research grant to Yale University to support the Collaboration for Research Integrity and Transparency. The sponsor had no role in the design or drafting of the manuscript and did not review the manuscript before submission. The views expressed are those of the authors.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0743.Corresponding Author: Harlan M. Krumholz, MD, SM, Yale School of Medicine, 1 Church Street, Suite 200, New Haven, CT 06510; e-mail, harlan.[email protected]edu.Current Author Addresses: Dr. Krumholz: Yale School of Medicine, 1 Church Street, Suite 200, New Haven, CT 06510.Ms. Kim: Yale Law School, 157 Church Street, 17th Floor, New Haven, CT 06510.Author Contributions: Conception and design: H.M. Krumholz.Analysis and interpretation of the data: J. Kim, H.M. Krumholz.Drafting of the article: J. Kim, H.M. Krumholz.Critical revision for important intellectual content: J. Kim, H.M. Krumholz.Final approval of the article: J. Kim, H.M. Krumholz.Administrative, technical, or logistic support: H.M. Krumholz.This article was published at Annals.org on 4 April 2017. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited by2017 Roadmap for Innovation—ACC Health Policy Statement on Healthcare Transformation in the Era of Digital Health, Big Data, and Precision Health 20 June 2017Volume 166, Issue 12Page: 893-894KeywordsClinical trialsComputed axial tomographyDisclosureForecastingResearch grantsScience policyScientists ePublished: 4 April 2017 Issue Published: 20 June 2017 Copyright & PermissionsCopyright © 2017 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...