Strategies for Responsible Sharing of Clinical Trial Data
Clinical trials are a crucial part of the development process for new medical products and represent a significant investment from all involved — patients 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 also could be used to benefit society by facilitating medical innovation. 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, an IOM committee will conduct a study to develop guiding principles and a framework for the responsible sharing of clinical trial data.
The study will produce an interim and final report. The interim report was released for public comment in January 2014 and included tentative findings on (a) guiding principles that underpin responsible sharing of clinical trial data and (b) a characterization of a selected set of data and data sharing activities (to clarify definitions and develop a shared nomenclature). Based on public comment on the interim report and on further deliberations, the committee is preparing a final report with findings and recommendations on the benefits and risks of sharing and not sharing clinical trial data and on opportunities to enhance responsible sharing of clinical trial data. The anticipated release date for the final report is December 2014.
The committee will meet approximately five times over the course of the study. The first committee meeting (October 22-25, 2013) featured open and closed sessions, and a full day of open sessions on Wednesday, October 23rd to inform the committee’s interim report. Subsequently, two public workshops were convened in conjunction with committee meetings in February and May 2014; to watch webcasts of these workshops click here and here. The remaining two meetings were closed meetings, during which the committee drafted and finalized the final report.
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Statement of Task
Learn more about the committee members
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