The high-profile debate throughout Europe on clinical trial data transparency has been mirrored in the US, particularly within the Institute of Medicine.
In follow up to its October 2012 workshop, the IOM is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data. A discussion framework has been issued, outlining 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.
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.