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 will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products. Those selected to the PEC are expected to serve for two years.

The eight new representatives are:

• Carol Abraham
• Julie Breneiser
• Sneha Dave
• Maria De Leon
• Sharon Lagas
• John Linnell
• James Pantelas
• Traceann Rose

The representatives were selected from more than 100 applications received in response to a Federal Register notice published in July 2021. 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 delighted to welcome the new members to the PEC and we extend our deepest thanks to those outgoing members for their important service and contributions,” said Sally Okun, CTTI’s executive director. “As CTTI works to advance our vision of Transforming Trials 2030, we anticipate that discussions with the PEC can help us identify opportunities to achieve our first pillar, in particular: ‘to make clinical trials patient-centric and easily accessible’. We can only accomplish this if we are on the journey together with patients.”

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 Office of Patient Affairs, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA.

“Understanding patients’ experiences is critical to informing medical product regulation and helping ensure that safe, effective and innovative medical products are available and meet the needs of patients as best as possible for improved quality of life. Learning from patients through the PEC helps the agency uphold its public health mission,” 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 and enhance the clinical trials enterprise. The next cohort of PEC members will identify topics to focus on. Previous topics have included: creating new ways to collaborate with patient communities; making patient engagement more systematic; improving transparency through education and outreach; 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:

• Dawn Aldrich
• Christine Brown
• Jeffrey Goldstein
• Melissa Hogan
• Nancy Lenfestey
• Stephanie Monroe
• Theresa Strong
• Dave White

The PEC has worked tirelessly to incorporate the patient voice in the FDA’s medical product regulatory programs. For example, the PEC has:

• Provided enhanced information to patient communities (e.g., for patients webpage).
• Created materials to help patients understand FDA’s mission/roles and patient engagement activities.
• Worked to better understand COVID-19’s impact on clinical trials for other diseases and conditions through informal discussions.
• Worked to understand patient concerns regarding COVID-19 vaccines.
• Met with the European Medicines Agency’s Patients’ and Consumers’ Working Party to exchange ideas around enhancing patient engagement, particularly incorporating youth perspectives.

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.