1. Pink Sheet

US FDA And Sponsors Resolve Disclosure Issues On Complex Trial Design Pilot Projects

 
• By Derrick Gingery

Agency officials can now discuss the ideas that have been accepted, though not in great detail.

Young businessman working on a virtual screen of the future and sees the inscription: Clinical trial
The FDA has accepted four proposals into its complex innovative trial design program, spanning neurology, analgesia and rheumatology. • Source: Shutterstock

Multiple complex innovative trial proposals have reached the US Food and Drug Administration, and maybe more importantly, now agency officials are talking about them.

The Complex Innovative Trial Design Pilot Program (CID) is intended to help sponsors test study designs so innovative that they may need simulations to determine operating characteristics, as well as...

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