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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

AAMC Joins IOM Discussion on Sharing of Clinical Trial Data

February 7, 2013—The Institute of Medicine (IOM) Feb. 3-5 convened a workshop on the responsible sharing of research data from clinical trials.  As part of the workshop, AAMC Chief Scientific Officer Ann Bonham, Ph.D., participated on a Feb. 4 expert panel discussing the cultural and financial incentives for data sharing.

In her remarks, Dr. Bonham noted increasing support for data sharing within the academic community as a means to expand scientific opportunity to ensure that data and other resources are maximally used to promote discovery and increase collaboration.  She expressed optimism that such sharing will increasingly be seen as an added dimension to scientific rigor in health research, on par with improved statistical analyses and other changes that have occurred over recent decades.

The session’s other panel members included Ira Shoulson, M.D., director of the Program for Regulatory Science and Medicine at Georgetown University School of Medicine, and Michael Rosenblatt, executive vice president and chief medical officer for Merck.

The IOM Committee on Strategies for Responsible Sharing of Research Data is charged in the coming year to develop principles that would guide when and how data from clinical trials are shared, and to recommend the “optimal” infrastructure and governance to enable such sharing.

Its deliberations take place as a growing international movement calls for broader access to data from clinical trials, in part to improve transparency and to help validate or compare findings from across many clinical trials, most of which are privately sponsored by commercial industry.

The IOM Jan. 27 issued a document on data sharing policies to frame this and continuing discussions.  Public comments are invited on the framework, due March 24, 2014.

Contact:

Alexander Ommaya, DSc.
Senior Director, Clinical Effec and Impl. Research
Telephone: 202-741-5520
Email: akommaya@aamc.org

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org