Volume 109, Issue 1, Pages 44–47

Authors:

Kurt T. Barnhart, M.D., M.S.C.E., Richard S. Legro, M.D., Richard T. Scott Jr., M.D.

Abstract:

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibility share data generated by interventional clinical trials (1). The goal of this opinion is that sharing of de-identified individual participant data will become the norm. The World Health Organization has articulated that best practice for clinical trials include: universal prospective registration, public disclosure of results, and data sharing. Achieving these goals will maximize generation of high quality data resulting in the practice of evidence based medicine, while concomitantly maximizing the ethical obligation to trial participants who put themselves at risk. The research community has started to adopt prospective clinical trail registration, while uptake is yet to be universal. Achieving the other goals, including data sharing, is both good and bad, and assuredly will be ugly.

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