Formats

FDA, CTTI Accepting Applications for Patient Engagement Collaborative (PEC)

Posted on by Hannah Faulkner

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.

 

 

New CTTI Publication Investigates Best Practices for Driving Adoption of Master Protocols

Posted on by Hannah Faulkner

In a new publication, CTTI applies expertise from industry sponsors, regulatory agencies, patient groups, and academic institutions to identify best practices for driving the widespread adoption of master protocols. Master protocol studies use a single protocol to guide the design and conduct of multiple sub-studies that can answer several questions at once—enabling patient-centric and efficient clinical research. Despite these benefits, adoption of master protocol studies remains limited. To facilitate broader adoption, CTTI conducted a landscape review and collected insights from multi-stakeholder expert meetings. Through these efforts, CTTI identified a broad set changes in the clinical trials ecosystem that would be needed for mainstream adoption master protocol studies: (1) the development of a harmonized global vision, (2) mobilization through the leadership of patients and academic groups, and (3) reinvention of operational processes and partnerships. The full publication, available in Clinical Trials, discusses the barriers to widespread adoption of master protocol studies and details potential solutions. The paper also highlights a suite of tools that CTTI has developed to support the design and conduct of high-quality, efficient master protocol studies.