FDA Establishes Center for Clinical Trial Innovation

FDA announced on April 15, 2024 that it has established the Center for Clinical Trial Innovation (C3TI) in the Center for Drug Evaluation and Research (CDER). C3TI was created in response to the need to enhance the implementation of CDER’s efforts to innovate and maximize drug development. The new center will promote activities CDER is doing to create innovation in clinical trials. These activities will include internal and external communications and collaboration.

Created as a central hub within CDER, C3TI will support approaches to clinical trials that will make drug development more efficient by sharing lessons learned across CDER’s existing initiatives in clinical trial innovation. C3TI will manage a demonstration program to expand opportunities for sponsors of trials to collaborate with CDER and spur additional implementation. This demonstration program will include point-of-care or pragmatic trials, Bayesian analyses, and trials that use selective safety data collection.

C3TI will allow internal and external parties to access information about innovation efforts, collaborate with CDER, identify resources, and identify development programs. The center will help those involved with clinical research stay current with innovations and improve the effectiveness of trials. It will also help to increase participation in clinical trials from diverse populations.

“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,” the agency stated in a press release.

A public docket was opened by CDER in 2023, and a two-day public workshop was held in March 2024,in collaboration with the Duke-Margolis Institute for Health Policy, to address how drug development could be improved by innovations in clinical trial approaches. According to Kevin Bugin, PhD, lead for C3TI and deputy director of operations in the Office of New Drugs (OND), “CDER staff noted they would benefit from greater exposure to or experience with the use of innovations in their regular review work. There is a desire across the drug development ‘ecosystem’ to integrate innovation, but there is a need for more direction on how to better bridge the gap between policy and implementation” (1).

“Based on this insight, C3TI will aspire to create more opportunities for staff to participate in development programs planning to implement novel trial approaches to gain experience with a given innovation, via a C3TI Demonstration Program. C3TI will also explore how to create new opportunities for CDER staff to receive training and exposure to new clinical trial methods, technologies, and tools. Lastly, C3TI intends to better capture and disseminate lessons learned from implementing a given clinical trial innovation through improved communication and coordination with colleagues (e.g., dedicated rounds to discuss clinical trial innovation) and with external parties (e.g., public meetings or webinars),” said Bugin.

“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, MD, director of CDER, in the press release. “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.”

Bugin stated that he plans for the center to accelerate innovation through collaboration and promotion of these initiatives. More information about C3TI can be found on FDA’s website (2).

References

1. FDA. CDER Launches a Center for Clinical Trial Innovation. FDA.gov, April 15, 2024. https://www.fda.gov/drugs/cder-conversations/cder-launches-center-clinical-trial-innovation
2. FDA. CDER Center for Clinical Trial Innovation (C3TI). FDA.gov (accessed April 15, 2024). https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti

Source: FDA