FDA Launches CDER Center for Clinical Trial Innovation (C3TI) to Boost Trial Design and Efficiency

1. The FDA has established the CDER Center for Clinical Trial Innovation (C3TI) to modernize and enhance clinical trial design, aiming to improve efficiency in drug development.
2. C3TI will serve as a central hub within CDER, promoting communication and collaboration both internally and with external parties.
3. The center's mission is to facilitate the sharing of lessons learned across CDER's existing clinical trial innovation initiatives and to manage a demonstration program for innovative clinical trials.
4. The initial project areas under the C3TI Demonstration Program include point-of-care or pragmatic trials, Bayesian analyses, and trials using selective safety data collection.
5. C3TI's goals are to assist researchers in staying current with clinical trial innovations, improve trial efficiency and effectiveness, increase diverse population participation, and accelerate the development of safe and effective new drugs.
6. The center was established based on the FDA's long-standing efforts to embed innovation in clinical trial design and conduct, as well as insights gained from interviews, listening sessions, a public workshop, and public docket.
7. C3TI will provide 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.
8. The FDA's vision for C3TI is to accelerate the pace of clinical trial innovation through collaboration and the promotion of best practices, ultimately benefiting drug development and patient access to new therapies.