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Boosting Complex Innovative Designs In Clinical Trials: What The Pilots Show

 
• By Brenda Sandburg

Lilly representative suggests having more informal communication with FDA and consistent feedback across divisions. The firm had a positive experience participating in CID pilot with master protocol for chronic pain therapies.

Clinical trial innovation
Case studies of clinical trials with complex innovative designs showcased at FDA workshop • Source: Shutterstock

Participants in the US Food and Drug Administration’s program for review of complex innovative designs in clinical trials gave behind-the-scenes perspective on their experience. While they noted the positive interactions with the agency, they suggested ways to speed up the process and sustain the use of these designs.

The agency held a public workshop earlier this month on advancing the use of complex innovative designs (CIDs) in clinical trials that included presentations on three case studies from FDA's CID pilot program and a discussion by a panel of experts from industry and academia

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