FDA

This virtual workshop, 'Clinical Trials: The Patient Experience', will feature a panel of rare disease patients, caregivers, and advocates who will share their experiences with gene therapy clinical trials.

As part of the FDA’s efforts to be responsive to the rapidly evolving clinical trial landscape and clarify the Agency’s recommendations on the conduct of DCTs, the FDA will provide an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.

This workshop will include presentations and panel discussions with representatives from drug sponsors, medical device sponsors, clinical research organizations, academia, patients, and other interested parties, who will share their experiences and approaches for increasing enrollment and encouraging participation of historically underrepresented populations in clinical studies.