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US FDA, Industry Share Early Lessons From Complex Innovative Trial Designs Program

 
• By Sue Sutter

Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.

Passenger airplane fly on a hight above overcast clouds and blue sky
US FDA and sponsors are piloting a new program on designing complex innovative trials. • Source: Shutterstock

Sponsor readiness, a well-thought-out trial design, and giving the US Food and Drug Administration all the data it needs to thoroughly vet a complex innovative study proposal are keys to a successful experience under the agency’s pilot program.

For the FDA’s part, it is working to ensure that staff involvement with a particular trial design does not end after the second of two meetings allowed under the pilot...

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