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1. Taichman DB, et al. Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Ann Intern Med 2017 [published on line]. doi:10.7326/M17-1028.
2. Rosenbaum L. Bridging the Data-Sharing Divide — Seeing the Devil in the Details, Not the Other Camp. N Engl J Med 2017;376:2201-2203. DOI: 10.1056/NEJMp1704482.
Data sharing has become nearly synonymous with ethical conduct of clinical trials. Patients have a right to know more and researchers have a responsibility to allow use of their data by colleagues to advance science. But have we put the cart before the horse; have we ensured that systems are in place that allow for positive outcomes related to data sharing? Two recent publications, briefly summarized below, address the issue from various sides of the argument.
In January 2016, the International Committee of Medical Journal Editors (ICMJE) issued a proposal that, if accepted, would have mandated all ICMJE member journals to require inclusion of de-identified patient-level data associated with published clinical trials as a condition of publication. Based on the hundreds of comments received, that ranged from applause to concerns about privacy, mechanisms for data management, and potential increase in cost of clinical trials, ICMJE revised and on June 6, 2017 released its data-sharing requirements as noted below:1
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