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.

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.

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.

The new PEC member application period is now open! On July 14, 2023, FDA and CTTI announced the call for applications for new members of the Patient Engagement Collaborative (PEC).

Please review the related Federal Register Notice for important information about the application process. PEC members participate in two to four virtual meetings per year. Up to 8 new members will be selected. Membership terms for new members will be 2-year appointments, beginning January 1, 2024. 

This announcement is open to receive a maximum of 75 applications. Applications will be accepted until 11:59 p.m. Eastern Time on August 14, 2023 or until 75 complete applications are received, whichever happens first. 

Interested candidates are encouraged to apply early. 

The following PDF format documents are required to apply and must be submitted at the same time:

• A current and complete one- to two-page resume or bio that summarizes your patient advocacy experience and related activities; and
• A one-page professional letter of endorsement from a patient group with which you have worked closely on activities that are relevant to the PEC  

For more information:

• Federal Register Notice
• PEC Application
• 2023 PEC Framework

Application Review Period

The application review period will take a minimum of 2 months after 11:59 p.m. Eastern Time on August 14, 2023. 

All applicants (both those selected for PEC membership and those who are not selected) will be notified of the final application decision no later than December 31, 2023. 

A selection committee consisting of patient advocates, staff from CTTI and the FDA review all applications and select qualified individuals. Applicants will be selected based on their ability to meaningfully contribute to the PEC, represent and express the patient voice for their constituency, work in a constructive manner with involved stakeholders, and understand and navigate the clinical research system.

CTTI and the FDA ensure involvement of representatives with a variety of diverse perspectives and experiences from patients, caregivers and patient organizations including but not limited to sociodemographic factors (such as age, gender, ethnicity, and education level) and disease experience.

Contact PatientEngagementCollaborative@fda.hhs.gov with questions.