The Clinical Trials Transformation Initiative (CTTI) and the US Food and Drug Administration (FDA) have selected a group of 16 patients, caregivers, and patient group representatives for the Patient Engagement Collaborative (PEC).
CTTI is the product of a public-private partnership between Duke University and the FDA, and aims to increase the quality of clinical trials.
According to CTTI, the PEC – which launched earlier this year – will meet with the FDA to discuss “communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products.”
The PEC will work to advance the FDA’s understanding of how to best engage across patient communities, CTTI project manager Zachary Hallinan told us: “Discussions may include making patient engagement more systematic; how to improve transparency, education, and communication; and new models for patients to collaborate as partners in the medical product development and FDA review process.”
“By ensuring that every step of medical product development accounts for patients’ needs, we can more effectively achieve higher quality, more efficient clinical trials,” he added.
Selection process
Nominations for PEC membership were received by a selection committee made up of patient advocates, CTTI staff members, and the FDA.
“Selection criteria included the nominee’s potential to meaningfully contribute to the activities of the PEC, to represent and express the patient voice for his or her constituency, to work constructively with involved stakeholders, and the nominee’s understanding of the clinical research enterprise,” said Hallinan.
“Consideration was also given to ensuring the PEC includes diverse perspectives and experiences, including but not limited to sociodemographic and disease experience diversity,” he added.
The names of the 16 patient advocates are listed here.