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On March 18, 2019, the Clinical Trials Transformation Initiative (CTTI) and FDA held a public workshop, “Enhancing the Incorporation of Patient Perspectives in Clinical Trials.” This workshop met an FDA commitment that is part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). Additional information can be found in the Federal Register Notice.

The purpose of this workshop was to seek ideas for best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial follow-up. This workshop gathered input from patients, caregivers, industry, academic researchers, and expert practitioners on the challenges and barriers to patient participation and retention in clinical trials.

For more information, please see CTTI’s Enhancing the Incorporation of Patient Perspectives in Clinical Trials webpage. A published report on proceedings and recommendations from the workshop is publicly available.

If you have any questions, please contact FDA’s CDER Patient-Focused Drug Development Program Staff by emailing [email protected].