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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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1. As of July 1, 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described in the publication.
2. Clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial’s registration. The ICMJE’s policy regarding trial registration is explained on their website. Any updates to the initial data sharing plan after trial registration should be included in the statement submitted and published with the manuscript, and updated in the registry record.
In the June 8, 2017, issue of the New England Journal of Medicine (NEJM), Lisa Rosenbaum, MD, shared her perspectives and some of the pros and cons associated with data sharing. According to Dr Rosenbaum, “The movement toward sharing data from clinical trials has divided the scientific community. On one side stand many clinical trialists, whose lifeblood — randomized, controlled trials (RCTs) — may be threatened by data sharing. On the other side stand data scientists — many of them hailing from the genetics community, whose sharing of data markedly accelerated progress in that field.”2
Dr Rosenbaum cited a question from a University of Oxford epidemiologist and trialist that she considered the most obvious one: “What problem are we trying to solve?” And, she goes on to question whether data sharing will accomplish the desired goal of advancement of science.
To read the ICMJE article in full, please visit: http://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf
To read the NEJM article in full, please visit: http://www.nejm.org/doi/full/10.1056/NEJMp1704482
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