FDA Patient Engagement Advisory Committee to Tackle Challenge of Clinical Trials

Posted July 28, 2017

The Food and Drug Administration’s (FDA’s) first advisory committee dedicated solely to patient-related issues will hold its inaugural meeting this fall. The focus will be clinical trials for medical devices.

“FDA chose this subject because patients often have concerns about participating in clinical trials or drop out once they have enrolled in a trial. Inconsistent or minimal participation in clinical trials can make it difficult to reach reliable conclusions or to determine the level of benefit for patients. It also can take longer to bring technological advances to the patients who need them,” the agency explained in a recent blog post authored by Kathryn O’Callaghan, assistant director for strategic programs in the FDA’s Center for Devices and Radiological Health (CDRH), and CDRH Director Jeffrey Shuren.

The meeting of the new Patient Engagement Advisory Committee (PEAC) will take place Oct. 11 from 1:00 p.m. – 5:00 p.m. and Oct. 12 from 8:00 a.m. – 5:00 p.m. at the Hilton Washington DC North/Gaithersburg. Attendees will discuss the challenges of clinical trial design, conduct, and reporting identified by patients. More information can be found in the Federal Register.

Although patient representatives currently participate in many FDA advisory committee meetings, the agency has never had a committee specifically dedicated to addressing patients’ needs, views, and concerns related to medical devices.

The PEAC, which is intended to be “a forum for the voice of patients,” is made up of nine voting members plus one non-voting industry representative and one voting consumer representative. Earlier this week, the FDA announced that the nine core voting members, including the chair and the consumer representative, all have direct experience as a patient or as a care-partner for a patient.

“They are experts in the field of patient engagement, and their experience extends beyond their personal disease or condition to the broader patient perspective, which is a critical piece of FDA’s work,” O’Callaghan and Shuren wrote.

The nine core members of the PEAC are:

  • Paul Conway (chair), president of the American Association of Kidney Patients
  • Katherine Seelman (consumer representative), professor emerita at the University of Pittsburgh (retired)
  • Cynthia Chauhan, a patient advocate
  • Amye Leong, president and CEO of Health Motivations, an independent consulting firm that specializes in medical motivation, patient-centered education, advocacy, and research strategies
  • Monica Willis-Parker, director of the minority engagement core at the Emory Alzheimer’s Disease Research Center
  • Frederick Downs, Jr., senior executive service chief procurement and logistics officer for the Veterans Health Administration (retired)
  • Bennet Dunlap, health communicator and advocate for people with diabetes
  • Deborah Cornwall, patient advocacy expert and longtime leadership volunteer for the American Cancer Society and the Cancer Action Network
  • Suzanne Schrandt, director of patient engagement at the Arthritis Foundation

New Issue of ‘BI&T’ Focuses on Partnering with Patients

The cover story of the July/August 2017 issue of BI&T explores how incorporating patient and user feedback into the design, approval, and use of medical devices can enhance care and improve patients' quality of life.

“There is plenty of evidence that when products of any kind are designed to meet customers’ needs, that’s a primary driver of their success,” said Patricia McGaffigan, vice president of safety programs for the newly merged National Patient Safety Foundation and Institute for Healthcare Improvement. “Collaborating with consumers is critical if you want your product to do well in the marketplace and, more importantly, play a meaningful role in their care.”

BI&T is AAMI’s bimonthly, peer-reviewed journal. Click here for more information about the July/August issue.