Report

Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities


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Clinical trials are crucial to determining the safety of medical interventions and their ability to achieve particular health outcomes and represent a significant investment from all involved — patients and others who volunteer to participate, organizations that sponsor trials, and the researchers who conduct a study and analyze the data. Clinical trial data represent potential resources that, if shared, could facilitate new analyses and a deeper understanding of a particular therapy or condition. However, much of the data generated by clinical trials is not public or shared beyond the data holder, and significant barriers to sharing these data exist. In follow up to an October 2012 workshop at the IOM, the IOM is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data. A final report will be released in December 2014.

This framework for discussion outlines the committee’s preliminary thoughts on guiding principles that underpin the responsible sharing of clinical trial data, defines key elements of data and data sharing activities, and describes a selected set of data sharing activities. One goal of this framework is to facilitate identification of the numerous complicated issues that the committee might need to take into account in the strategies and practical approaches to sharing of clinical trial data that will be recommended in the committee’s final report.

As required in the charge to the committee, Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is being released for public comment. The committee welcomes comments from the public to help ensure that major concerns and areas are not overlooked. Comments may be submitted to the committee at either of two forthcoming public workshops, or via the committee’s project website. Comments will be most useful if submitted by March 24, 2014. The committee expects to release its final report with findings and recommendations on strategies and practical approaches to responsible data sharing in late 2014.

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