U.S. flag An official website of the United States government
  1. Home
  2. For Patients
  3. Learn About FDA Patient Engagement
  4. Patient Engagement Collaborative
  1. Learn About FDA Patient Engagement

Patient Engagement Collaborative

Jan. 9, 2023: Eight new PEC members have been selected. Please see Patient Engagement Collaborative Announces Eight New Members for more information.

The Patient Engagement Collaborative (PEC) is a group of patient organizations and individual representatives who discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions at the FDA.

The PEC was established by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership that brings together organizations and individuals representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups and others to develop evidence-based solutions to clinical research challenges.

PEC establishment

PEC Logo

In 2017, patient communities commented in public feedback to create an outside group to provide input on patient engagement across the agency. In response to that feedback and with help from patient organization representatives, the FDA and CTTI established the PEC. The PEC was modeled after the European Medicines Agency’s (EMA) Patients’ and Consumers’ Working Party. The PEC is facilitated by federal law to foster patient participation and incorporate patient experiences in the regulatory process.

PEC discussion topics

Woman leading discussion at table

The PEC is an ongoing forum to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions.
Discussion topics may include:

  • Creating new models for patients to collaborate as partners in the medical product development and regulatory review process
  • Making patient engagement more systematic
  • Improving transparency
  • Enhancing communication tools between the FDA and patient community
  • Developing educational tools on the medical product regulatory process.

PEC members

Two men at table talking

Representatives from the patient community who participate in the PEC include:

  • Patients
  • Caregivers who have personal experience supporting someone with a health condition. A caregiver can be a parent, child, partner, family member, or friend.
  • Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience.

See CTTI’s Patient Engagement Collaborative page for a full member list and more information about the PEC.

PEC member selection process

Application Checklist

Following an official call for applications, a selection committee consisting of patient advocates, staff from CTTI and the FDA chooses individuals to serve as PEC members. CTTI and the FDA ensure involvement of representatives with a variety of perspectives including patients, caregivers and diverse representatives from patient organizations. PEC members are expected to serve for two to three years.


Meeting summaries

Contact PatientEngagementCollaborative@fda.hhs.gov with questions about the Patient Engagement Collaborative.



Back to Top