The FDA and CTTI will be accepting applications this summer from patient community representatives interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, shared forum where patient community representatives and regulators come together to discuss strategies for increasing patient engagement. Get ready to apply so you don’t miss your chance to join this unique group!  

Successful applicants will include:  

• Patients who have personal disease experience  
• Caregivers who support patients (e.g., a family member or friend) and have personal disease experience through this caregiver role  
• Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience  

The following PDF documents are required to apply:  

• A current and complete one- to two-page resume or bio that summarizes your patient advocacy experience and related activities (PDF format required); 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 (PDF format required)  

A maximum of 75 applicants will be considered. If you or someone you know may be interested in applying, please check the FDA’s PEC webpage for details.  

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 engage the FDA about medical product regulation. Those selected to the PEC are expected to serve for two years. 

The eight new representatives are:  

• Kim Hindery 
• Yasmin Ibrahim 
• Seth Morgan 
• Cara O’Neill 
• Ceciel Rooker
• Christina Sisti
• Trina Stelly
• Lauren Youngborg

The representatives were selected from 75 applications received in response to a Federal Register notice published in September 2022. 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 of the PEC and we sincerely appreciate the contribution of those outgoing members and extend our deepest thanks for their dedication and service,” said Sally Okun, CTTI’s executive director. “Including patients as equal partners in clinical research is a foundational value of CTTI. Discussions with the PEC contribute to advancing our vision of Transforming Trials 2030, in particular our first pillar: ‘to make clinical trials patient-centric and easily accessible’.” 

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 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 support medical product regulation and help ensure safe, effective and innovative medical products are available for patients. The PEC is an important opportunity for individuals to share their experience with the FDA. The FDA listens closely to feedback from individuals in the PEC and uses the insight from the PEC to enhance engagement opportunities and provide a platform for patients’ voices to be heard,” 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. 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: 

• Ronald Bartek 
• Anne Hall 
• Elizabeth Joniak-Grant 
• Isabelle Lousada 
• Rick Phillips
• Philip Posner
• Lynne Quittell
• Adrienne Shapiro

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 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 in 2021 to exchange ideas around enhancing patient engagement, particularly incorporating youth perspectives and in 2022 to discuss COVID-19 communication.  

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. 

The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum where patient community representatives and regulators come together to discuss strategies for increasing patient engagement in medical product development and regulatory discussions at the FDA.

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 ecosystem.

Successful applicants will include:

• Patients who have personal disease experience
• Caregivers who support patients (e.g., a family member or friend) and have personal disease experience through this caregiver role
• Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience

PEC members participate in working meetings two to four times per year, either in person (in the Washington D.C. area) or virtually. Given the ongoing COVID-19 pandemic, meetings will be conducted virtually and may resume in-person when it is safe to do so. Additionally, PEC members participate in monthly one-hour teleconferences and other meetings may be organized as needed.

A maximum of 75 applicants will be considered for PEC membership and up to eight members will be selected. Interested applicants are encouraged to complete and submit the online form starting at 10:00 a.m. EDT on September 19, 2022. The application will remain open until 75 completed applications have been submitted. Those who are unable to submit an application electronically are encouraged to call the FDA’s Office of Patient Affairs at 301-796-8460 to arrange for a mail submission.

Please review the related Federal Register notice for important information about the application process.

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.

The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum that brings the patient community and regulators together to discuss ways to increase patient engagement in medical product development and regulatory discussions at the FDA.

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 ecosystem.

Successful applicants will include:

• Patients who have personal disease experience
• Caregivers who support patients, such as a family member or friend, and who have personal disease experience through this caregiver role
• Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience

PEC members will be expected to participate in working meetings two to four times per year, either in-person (in the Washington D.C. area) or virtually. Given the ongoing COVID-19 pandemic, meetings will be conducted virtually and may resume in-person when it is safe to do so. Additional meetings may be organized as needed, and currently include monthly, one-hour teleconferences.

Interested applicants are encouraged to complete and submit the online form no later than 11:59 p.m. ET on August 23, 2021. Those who are unable to submit an application electronically are encouraged to call the FDA’s Office of Patient Affairs at 301-796-8460 to arrange for a mail submission.

Please review the related Federal Register notice for important information about the application process.