FDA Commits to Patient Engagement at Inaugural Advisory Committee Meeting

Examining how well medical device companies engage with patients in clinical trials is becoming part of the new normal at the FDA, say agency officials.

The inaugural meeting last week of the Patient Engagement Advisory Committee featured FDA moderators leading multiple roundtable discussions with patients of a hypothetical study on methods to boost clinical trial enrollment and retention, keeping patients engaged from the design phase through recruitment and follow-up, and how companies should communicate study results to participants.

The latest reauthorization of MDUFA provided money for the first time to build out the center’s patient engagement efforts, Shuren said. The center is also planning a Patient Organization Awareness Day for Nov. 15.