FDA Guidance Directs Researchers On Use Of Patient Advocates

In recent years, the medical device industry has become increasingly aware of the important role patients should play in developing new technologies. However, shaping that engagement during the clinical trial process has remained a challenge. A new draft guidance document from the US Food and Drug Administration attempts to fill that gap by discussing ways sponsors can use patient experience and perspectives to better the design and conduct of device clinical trials.

Discussions at the October 2017 meeting of the Patient Engagement Advisory Committee (PEAC) shaped the document, acting FDA commissioner Ned Sharpless says. The meeting, which focused on overcoming barriers to...