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 In this section:

                Learn About FDA Patient Engagement

Learn About FDA Patient Engagement

                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities Home
          For Patients
          Learn About FDA Patient Engagement
          Patient Engagement CollaborativeLearn About FDA Patient Engagement Patient Engagement Collaborative
  
  	
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    PrintThe FDA and CTTI announced 8 newly selected representatives for the PEC with 2-year terms starting in January 2024. They will join the existing 8 members. An updated list of all members is available.


The Patient Engagement Collaborative (PEC) is a joint project between the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI). The PEC is an ongoing, shared setting in which the patient community (PEC members), FDA, and CTTI discuss many topics for improving communication, education, and patient engagement related to medical product regulation. PEC Framework

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 activities of the PEC may guide some FDA and CTTI activities. The PEC is not considered an FDA advisory committee and activities are not intended to advise or direct the activities of either organization.

PEC meetings are not directly related to regulatory policy decisions and are non-committal. The group does not discuss specific medical products or treatments and tries to avoid topics that are not part of FDA’s authority, such as patient concerns about insurance coverage and medical costs.

The PEC is a chance for the patient community to discuss and exchange views and perspectives (ideas and experiences). The PEC serves as a shared setting in which the patient community, FDA, and CTTI discuss a range of topics for enhancing communication, education, and patient engagement related to medical product regulation. The activities of the PEC may include, but are not limited to, the following:

Communication and Education

Assist sorting out topics of shared interest to the PEC, CTTI, and the FDA
	Examples may include, but are not limited to, clear ways for patients to engage, communicate, and understand FDA policies.
	Identify possible needs for communication tools and educational resources for patient communities (patients, caregivers and advocates)
	Contribute to the development of communication tools and educational resources, such as patient focused webpages, background information on the role of the FDA, etc.
	Increase awareness and take part in two-way education about medical product regulation in patient communitiesEngagement

Share information and experiences from patient communities on topics to inform patient engagement activities
	Explore new and creative ideas to enhance patient engagement
	Collaborate with the FDA/CTTI to inform their communities about public meetings and resources from the FDA/CTTI


PEC members

Two men at table talking
 The PEC is comprised of up to 16 wide-ranging representatives of the patient community. To avoid gaps in its activities and maintain group knowledge, the PEC maintains overlapping membership terms, rotating eight members in/out annually. Membership terms are 2 years.

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
 The 2023 PEC member application period is now closed. This webpage will be updated when the next application period opens in 2024.

In January 2024, 8 new members started 2-year membership terms and will join the 8 continuing members.

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.



**Meeting summaries**

Patient Engagement Collaborative Meeting (July 20, 2023)
	Patient Engagement Collaborative Meeting (May 11, 2023)
	Patient Engagement Collaborative Meeting (February 23, 2023)
	Patient Engagement Collaborative Meeting (September 21, 2022)
	Patient Engagement Collaborative Meeting (July 15, 2022)
	Patient Engagement Collaborative Meeting (April 28, 2022)
	Patient Engagement Collaborative Meeting (January 27, 2022)
	Patient Engagement Collaborative Meeting (July 1, 2021)
	Patient Engagement Collaborative Meeting (October 5-6, 2020)
	Patient Engagement Collaborative Meeting (April 29, 2020)
	Patient Engagement Collaborative Meeting (September 11, 2019)
	Patient Engagement Collaborative Meeting (March 20, 2019)
	Inaugural Patient Engagement Collaborative Meeting (August 29, 2018)Contact PatientEngagementCollaborative@fda.hhs.gov with questions about the Patient Engagement Collaborative.

                                                                                  Content current as of:
      01/11/2024
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical DevicesLearn About FDA Patient Engagement

          
                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities
 
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