FDA to Convene Committee Seeking Patient Engagement Feedback

In an effort to brainstorm strategies that will boost patient engagement in medical device development, the FDA has announced it will host the first meeting of its Patient Engagement Advisory Committee (PEAC) this fall.

The first meeting of the new committee, set for October 11-12, will focus on clinical trials. Specifically, the public meeting will bring the committee together along with patient advocates and medical experts to discuss patients’ opinions on participation barriers and other challenges like trial design, according to the FDA Voice blog post announcing the meeting.

The blog post touted the fact that all 9 voting members of the PEAC have personal experience as a patient or caregiver, including chair Paul Conway, president of the American Association of Kidney Patients, who has managed his own kidney disease for over 37 years. Consumer representative Katherine Seelman, PhD, a former professor at the University of Pittsburgh, is hearing impaired and has partaken in a number of initiatives to expand accessibility for those with disabilities.

According to the blog post from the FDA’s Center for Devices and Radiological Health (CDRH), the PEAC is the result of a 2012 law requiring the agency to “solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussion.”

In the post, co-authors Kathryn O’Callaghan, CDRH assistant director for strategic programs, and Jeffrey Shuren, MD, JD, director of CDRH, outlined the 3 main goals of PEAC:

• To more fully appreciate patient perspectives and incorporate them into FDA oversight policies
• To effectively communicate the benefits, risks, and clinical outcomes of medical devices to patients
• To pinpoint innovative approaches and overlooked risks, barriers, and consequences from the use of medical devices.

The topic of clinical trials was chosen for the inaugural meeting due to patients’ reported wariness about taking part in such trials and the struggle of retaining patients in trials once they are underway. Fewer patients participating in clinical trials makes it harder to interpret trial results and generalize them to the broader patient population, which can delay market entry of new therapeutic devices.

The PEAC will be the first FDA committee to completely focus on patients, the blog post notes, although patient advocates are encouraged to voice their perspectives in other FDA advisory committee meetings. According to O’Callaghan and Shuren, the PEAC is part of FDA’s ongoing mission to acknowledge the patient perspective, since patients and their caregivers are the true experts on the daily burden of their illnesses.

Along with findings from research on patient engagement, the feedback collected at the PEAC meetings will be used to adjust the FDA’s policies to better align with the balance of benefits and risks as perceived by patients.

“Patients are at the heart of what we do,” O’Callaghan and Shuren concluded. “It makes sense to establish an advisory committee built just for them.”