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 caregivers, patients, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communications, 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:

• Bernard Coley
• Lisa Craine
• Rebecca Esparza
• Syreen Goulmamine
• Heather Guidone
• Carter Hemion
• Toni Jaudon
• Mary Anne Meskis

The representatives were selected from 75 applications received in response to a Federal Register notice published in July 2024. These new members of the PEC include caregivers who have personal experience supporting someone with a health condition, patients who have personal disease experience, and representatives from patient groups who have direct or indirect disease experience. The selection committee, which included 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.

The PEC, a collaboration established by the FDA and CTTI in 2018, is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. The FDA and CTTI collaborate to involve representatives with a variety of perspectives including caregivers, patients, and representatives from diverse patient organizations and communities. The PEC is run by the FDA’s Public Engagement Staff, which is responsible for communicating, educating, and engaging with external partners including academia, caregivers, consumers, health care providers, patients, and trade associations on the agency’s policy priorities.

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 the FDA and CTTI activities to share with patient communities. Previous topics have included: increasing awareness of existing engagement mechanisms among patients and patient groups; increasing patients’ education to empower them to act as representatives of their broader community; enhancing communication between the FDA and patient communities; and promoting global collaboration of patient organizations.

The FDA and CTTI wish to thank the outgoing members for their service to the PEC over the past several years:

• Kim Hindery
• Yasmin Ibrahim
• Seth Morgan
• Cara O’Neill
• Ceciel Rooker
• Christina Sisti
• Trina Stelly
• Lauren Youngborg

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.