By: Andrea C. Furia-Helms, M.P.H., Director of Patient Affairs, Office of Clinical Policy and Programs
Patients are at the heart of the U.S. Food Drug Administration’s mission. Understanding patients’ experiences is critical to support medical product regulation and help ensure safe, effective and innovative medical products are available. Learning from patients helps the agency uphold its public health mission.
Today, the FDA announced the call for applications for the next cohort of the Patient Engagement Collaborative (PEC). The PEC, established in 2018 in collaboration with the Clinical Trials Transformation Initiative (CTTI), is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. CTTI and the FDA collaborate to involve representatives with a variety of perspectives including patients, caregivers and representatives from diverse patient organizations. The PEC is run by the FDA’s Patient Affairs staff, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA.
The call for applications is to identify individuals interested in serving as members of the PEC. The application period is open for 30 days. PEC members are expected to serve for two to three years. A selection committee consisting of patient advocates, staff from CTTI, the FDA and patient representatives, will select individuals to serve as members following this formal call for applications.
The PEC is an important opportunity for individuals to share their experience with the FDA and help inform medical product regulation. This is a forum for patients’ voices to be heard and to advocate for patients who are seeking different health outcomes. The FDA listens closely to feedback from individuals in the PEC and uses the insight from patients to inform regulatory decision making. The agency encourages interested individuals to participate in this unique opportunity to help advance public health.
Representatives from the patient community who participate in the PEC include:
- Patients who have personal disease experience.
- Caregivers who have personal experience supporting someone with a health condition (e.g., a parent, child, partner, family member or friend).
- Representatives from patient groups who have direct or indirect disease experience.
The PEC discusses topics such as:
- Creating new ways to collaborate with patient communities.
- Making patient engagement more systematic.
- Improving transparency through education and outreach.
- Enhancing communication between the FDA and patient communities.
The members serving on the PEC have 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).
- 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.
Going forward, the PEC will continue the dialogue around how patient experiences can inform the FDA’s work and continue working to improve communication and engagement activities between the agency and patients. The next cohort of PEC members will identify topics to focus on moving forward.
The FDA offers multiple engagement opportunities for patients and caregivers, and the agency takes the opportunity to hear from patients very seriously. The insight gained from patient input has been invaluable and directly supports the FDA’s public health mission. The agency is eager to learn from patients and encourages patients to ask FDA questions or request a meeting.