Toward Fairness in Data Sharing | NEJM

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"The International Committee of Medical Journal Editors (ICMJE) has proposed a plan for sharing data from randomized, controlled trials (RCTs) that will require, as a condition of acceptance of trial results for publication, that authors make publicly available the deidentified individual patient data underlying the analyses reported in an article.1 Before any data-sharing policy is enacted, we believe there is a need for the ICMJE, trialists, and other stakeholders to discuss the potential benefits, risks, and opportunity costs, as well as whether the same goals can be achieved by simpler means. Although we believe there are potential benefits to sharing data (e.g., occasional new discoveries), we believe there are also risks (e.g., misleading or inaccurate analyses and analyses aimed at unfairly discrediting or undermining the original publication) and opportunity costs (e.g., the ICMJE proposal would have enormous direct costs and would probably divert resources, both financial and human, from the actual conduct of trials). In 2010 alone, results of more than 27,000 RCTs were published.2 We believe consideration needs to be given to whether it is worthwhile to undertake data sharing for all published trials or just for those whose results are under question or those that are likely to influence care...."



02/02/2021, 11:17

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Date tagged:

02/02/2021, 16:17

Date published:

08/04/2016, 12:17