[4/15/2024] Today, FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.
“CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need,” said Patrizia Cavazzoni, M.D., director of CDER. “We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.”
For years, CDER has championed innovation, and our activities to foster and support innovation span drug development programs, therapeutic areas, and disciplines. These CDER efforts have led to improvements in the design and conduct of clinical trials that are intended to efficiently generate evidence on the safety and effectiveness of new therapies in ways that meet the growing demands of drug development.
Recently, we sought to understand the impact of these efforts by holding interviews, listening sessions, and a public workshop with both internal and external parties, and soliciting comments to a public docket. Based on these engagements, we recognize an opportunity to enhance the implementation of our innovative efforts and maximize the impact on drug development.
C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development. C3TI will facilitate the sharing of lessons learned across CDER’s existing clinical trial innovation initiatives and will communicate and collaborate with external parties. C3TI will also manage a demonstration program that will expand opportunities for sponsors of innovative clinical trials to interact with CDER staff and for these trials to serve as case examples to spur further implementation. The three initial project areas under the C3TI Demonstration Program are 1) point-of-care or pragmatic trials; 2) Bayesian analyses; and 3) trials using selective safety data collection.
This new center within CDER will enable both internal and external parties to access information on clinical trial innovation efforts more easily, engage in collaborations, identify resources that can further support the use of innovative modalities, and identify development programs where a concerted approach to the use of clinical trial innovations would be impactful. The goals of these efforts are to assist those involved in clinical research in staying current with clinical trial innovations, improve the efficiency and effectiveness of clinical trials, help increase the participation of diverse populations in clinical trials, and, in turn, accelerate the development of safe and effective new drugs.
For more information about C3TI, including how to participate in a project in the C3TI Demonstration Program, explore the C3TI webpage. Visit the CDER Conversation with Dr. Kevin Bugin, deputy director for operations in CDER’s Office of New Drugs and lead for C3TI to learn more about the impetus for establishing C3TI and the center’s forward-facing goals and objectives.