FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA and CTTI Launch Patient Forum to Boost Engagement in Drug Development

Jan. 11, 2018

The Patient Engagement Collaborative is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between the FDA and Duke University.

The FDA and CTTI are seeking a diverse group of representatives for the 16-member panel, in order to help the agency best understand how to engage across patient communities, according to Rachel Sherman, the FDA’s principal deputy commissioner. About half of the members will be selected from CTTI member organizations and individuals, although self-nominations are accepted.

 The panel will act as a forum for discussing new methods to increase patient participation in the agency’s decisionmaking process. It will provide input on incorporating patient-preferences into reviews of medical products and trial protocols to make patient engagement an integral part of drug development.

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