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CTTI Cited during the FDA’s Patient Engagement Advisory Committee Inaugural Meeting

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:

  • Engage the “patient voice” by establishing partnerships from the beginning of the research and development program to improve trial design and execution
  • Clearly define the expectations, roles, and responsibilities of all partners, including the resources being committed, data being shared, and objectives of the program
  • Manage real or perceived conflicts of interest by establishing policies that require full disclosure, transparency, and accountability

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.