FDA wants to boost trial innovation with new center at CDER

The FDA's Center for Drug Evaluation and Research, or CDER, has established a new center for communication between CDER staff and stakeholders involved in clinical trials, according to an April 15 announcement. The end goal is to modernize clinical trials by making it easier for sponsors to innovate on their design. 

Called the CDER Center for Clinical Trial Innovation, or C3TI, the hub will include what its lead Kevin Bugin, Ph.D., described in a video as a “centralized knowledge repository” for sharing information about clinical trial innovation. It will also work with trial sponsors on special projects related to trial innovation under what it is calling the “Demonstration Program” and will coordinate communication between sponsors and the FDA.

“Our ultimate goal for C3TI is to accelerate the adoption of clinical trial innovation and our day-to-day regulatory work and bridge the gaps between research implementation and policy development,” Bugin said, adding that participation from stakeholders would be necessary for “real practical progress.” 

C3TI’s launch comes after the FDA’s March 2024 workshop and a public docket opened in October 2023 on ways to improve innovation in clinical trials. Thirty stakeholders—including Eli Lilly, Astrazeneca, the Biotechnology Innovation Organization, Medicines360 and others—shared public comments with the FDA as part of the process. 

In its comment, Lilly agreed with the FDA’s recent conclusion that innovative trial design in drug development was “opportunistic and heterogeneous,” a problem the pharma linked to regulatory frameworks that haven’t “kept up with the breadth and pace of change and advancement in the industry.” The agency is also inconsistent in whether it accepts certain statistical approaches for trial design and the use of real-world evidence, Lilly said.

“FDA staff in some therapeutic areas are more familiar and seem more open to innovative approaches than others,” Lilly’s comment read. 

C3TI won’t solve such issues overnight. But it does aim to make it easier to share lessons learned across its own clinical trial innovation programs and to give trial sponsors a chance to work with CDER experts to demonstrate the value of new approaches, as Bugin noted in a separate article about the new center. 

“While guidance documents have been critical to guide clinical trial innovation, real-world examples help us better understand how to implement these innovations,” Bugin said. “The experience from these examples, either identified by C3TI and its partners or generated through the Demonstration Program, can be shared broadly.” 

In the near term, C3TI will open up applications for its Demonstration Program to sponsors in three initial project areas who want their trials to serve as case studies. Experts from the center will also hold additional working groups and public workshops to offer guidance on trial design. 

“As C3TI is fully implemented, we hope to increase engagement with sponsors,” Bugin concluded in the article. “We look forward to C3TI’s growth over the years to come and its positive impact on drug development.”