The US Food and Drug Administration (FDA) has tapped the Clinical Trials Transformation Initiative (CTTI) to support its Patient Engagement Collaborative.
CTTI is a public-private partnership co-founded by Duke University and the FDA with the goal of increasing the quality of clinical trials.
The new collaborative will be an ongoing forum through which the patient community and regulators will discuss communication, transparency, and new ways for patients and the FDA to work together, explained Zachary Hallinan, CTTI project manager.
The FDA is seeking nominations to join the Patient Engagement Collaborative through January 29, 2018.
“CTTI and the FDA believe that furthering the engagement of patients as valued partners across the research and development continuum requires an open forum for patients and regulators to discuss and exchange ideas,” Hallinan said.
Creation of the collaborative follows public feedback the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA).
As part of this feedback, Hallinan explained that it was suggested an outside group be created to provide input on patient engagement.
“The goal in creating this collaborative is to bring together members of the patient community to discuss the best ways for patients to participate in the FDA’s regulatory discussions about medical products,” he added.
“Engaging patients as partners in the development of medical products is critical to the success of the clinical research enterprise.”