CTTI Project: Patient Group Engagement
Webinar Presenters:
- Joseph DiMasi (Tufts Center for the Study of Drug Development)
- Jaye Bea Smalley (formerly of Celgene)
Patient Engagement
Now Accepting Applications for FDA and CTTI Patient Engagement Collaborative (PEC)
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, shared forum in which the patient community (PEC members), FDA, and CTTI discuss a range of topics for enhancing communication, education, and patient engagement related to medical product regulation.
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 relevant individuals and organizations, and understand and navigate the clinical research system. The two-year term will begin January 1, 2025.
Successful applicants will include:
- Patients who have personal disease experience
- Caregivers who directly 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 5-6 virtual meetings per year. Other meetings may be organized, as needed.
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
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 on July 9, 2024 at 11:59 p.m. A maximum of 75 completed applications will be considered.
Applications will be accepted until 11:59 p.m. Eastern Time on August 8, 2024 or until 75 complete applications are received, whichever happens first.
Those who are unable to apply electronically are encouraged to call FDA 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.
For more information:
Patient Engagement Collaborative (PEC) Application to Open Soon
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.
New CTTI Steering Committee Positions Open for Patient/Caregiver Representative(s)
One of the ways that the Clinical Trials Transformation Initiative (CTTI) engages with and integrates patients into our work is by having patient/caregiver representatives on our Steering Committee. We are currently accepting applications for this position until 11:59 p.m. ET, Tuesday, April 2. We are looking for patients or caregivers who are self-starters, have personal experience and familiarity with clinical trials, and can work with stakeholders across the research community.
During their three-year term, CTTI Steering Committee patient/caregiver representatives contribute ideas for projects, participate in their conduct and analysis, and are committed to disseminating CTTI recommendations and encouraging adoption of system changes that will improve the efficiency and quality of clinical trials.
To learn more about this opportunity and apply, please visit the patient/caregiver page on our website. You can also meet our current patient/caregiver representatives.
Patient Engagement Collaborative Announces Eight New Members
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 meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation. Those selected to the PEC are expected to serve for two years.
The eight new representatives are:
- Anna Ball
- Kelly Barta
- Ricki Fairley
- Liam McCarthy
- Andrea Meredith
- Patrick Moeschen
- Olga Torres
- Kathryn Washington
The representatives were selected from 75 applications received in response to a Federal Register notice published in July 2023. 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 thrilled once again to have eight new members of the PEC who will share their insights on patient engagement and research. CTTI’s Transforming Trials 2030 pillars envision a system that representative, accessible, and directly informed by patient preferences and experiences. Having patients as partners, especially through the PEC, is critical to our work. We also wish to thank the outgoing members for their invaluable perspectives during their term,” said Morgan Hanger, CTTI’s Executive Director.
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.
“Patient community experiences and opinions are essential to inform FDA’s regulatory work. The FDA listens closely to PEC members to integrate different perspectives into meaningful patient engagement and communication opportunities.” 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 the clinical trials enterprise and provide information and resources to enhance PEC members’ knowledge about FDA and CTTI activities to share with patient communities. Previous topics have included: providing enhanced information to patient communities to clarify FDA’s role; updating the PEC Framework; working to better understand COVID-19’s impact on clinical trials; creating new ways to collaborate with patient communities; promoting global collaboration of patient organizations; 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:
- Carol Abraham
- Julie Breneiser
- Sneha Dave
- Maria De Leon
- Sharon Lagas
- John Linnell
- James Pantelas
- Traceann Rose
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.