Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation. Those selected to the PEC are expected to serve for two years.
The eight new representatives are:
- Anna Ball
- Kelly Barta
- Ricki Fairley
- Liam McCarthy
- Andrea Meredith
- Patrick Moeschen
- Olga Torres
- Kathryn Washington
The representatives were selected from 75 applications received in response to a Federal Register notice published in July 2023. These new members of the PEC include patients who have personal disease experience, caregivers who have personal experience supporting someone with a health condition, and representatives from patient groups who have direct or indirect disease experience. The selection committee, which included patient advocates, FDA staff from multiple centers, CTTI staff and several outgoing PEC members, worked to identify individuals with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.
“CTTI is thrilled once again to have eight new members of the PEC who will share their insights on patient engagement and research. CTTI’s Transforming Trials 2030 pillars envision a system that representative, accessible, and directly informed by patient preferences and experiences. Having patients as partners, especially through the PEC, is critical to our work. We also wish to thank the outgoing members for their invaluable perspectives during their term,” said Morgan Hanger, CTTI’s Executive Director.
The PEC, a collaboration established by FDA and CTTI in 2018, is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. FDA and CTTI collaborate to involve representatives with a variety of perspectives including patients, caregivers and representatives from diverse patient organizations and communities. The PEC is run by the FDA’s Patient Affairs, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA.
“Patient community experiences and opinions are essential to inform FDA’s regulatory work. The FDA listens closely to PEC members to integrate different perspectives into meaningful patient engagement and communication opportunities.” said Andrea Furia-Helms, M.P.H., Director of Patient Affairs, Office of Clinical Policy and Programs, FDA.
Going forward, the PEC will continue the dialogue around how patient perspectives can inform the clinical trials enterprise and provide information and resources to enhance PEC members’ knowledge about FDA and CTTI activities to share with patient communities. Previous topics have included: providing enhanced information to patient communities to clarify FDA’s role; updating the PEC Framework; working to better understand COVID-19’s impact on clinical trials; creating new ways to collaborate with patient communities; promoting global collaboration of patient organizations; and enhancing communication between the FDA and patient communities.
The FDA and CTTI wish to thank the outgoing members for their service to the PEC over the past several years:
- Carol Abraham
- Julie Breneiser
- Sneha Dave
- Maria De Leon
- Sharon Lagas
- John Linnell
- James Pantelas
- Traceann Rose
Since 2008, CTTI has included patient advocates on its Executive Committee, Steering Committee, and project teams and, today, nearly all of its more than 30 sets of evidence-based recommendations and associated frameworks and tools mention inclusion of patients as a critical part of the clinical trials process.