Fierce Biotech April 17, 2024
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...
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