Findings and recommendations from CTTI’s Patient Groups & Clinical Trials work were presented during the inaugural meeting of the FDA’s Patient Engagement Advisory Committee (PEAC) on Oct. 11-12, 2017.
At the meeting, Bray Patrick-Lake, director of stakeholder engagement, Duke Clinical Research Institute, discussed patient engagement efforts in the clinical trial enterprise and presented work conducted by CTTI to establish best practices for effective engagement with patient groups around clinical trials, which include:
The PEAC is composed of patients and caregivers who provide perspective to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. This first meeting brought together patients, patient organizations, FDA, industry, and other medical and scientific experts for discussion on incorporating patient perspectives in the design, conduct, and reporting of medical device clinical trials.
Meeting materials, including slide presentations, are available on the FDA website.