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C3TI's Mission: Leverage FDA Trial Innovation Expertise, Educate Inspectors

 
• By Sue Sutter

The Center for Clinical Trial Innovation was created to be CDER’s hub for expertise and information on innovative clinical trial approaches. C3TI lead Kevin Bugin talks to the Pink Sheet about the program's genesis and what it hopes to accomplish.

Teamwork
C3TI's demonstration program will leverage expertise from throughout CDER on innovative trial designs. • Source: Shutterstock

The US Food and Drug Administration’s drugs center plans to leverage its new Center for Clinical Trial Innovation (C3TI) not only as a hub for experience with innovative trial approaches, but also to alleviate fears that the agency’s inspectors will not understand the strategies and that global regulators will not accept them.

Key Takeaways

  • Under C3TI’s demonstration program, experts will be pulled from across CDER to meet with sponsors on innovative trial designs.

  • Since its launch in April, C3TI has not received any formal proposals for the demonstration program, but has received several “soft inquiries

C3TI is intended to build on the momentum and progress made to date in incorporating novel and emerging approaches in clinical trials, said Kevin Bugin, deputy director

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