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Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

 
• By Brenda Sandburg

Draft guidance specifies documentation that must be submitted to FDA prior to conducting an adaptive trial, and what to include in an application.

adaptive design - text in vintage letterpress wood type against grunge metal surface

The US FDA's new draft guidance on clinical trial adaptive designs lists the information sponsors must submit to the agency before initiating a trial and what data they should include in their applications.

The agency issued the draft guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics, on Sept. 28. The document replaces a 2010 draft guidance. Like the earlier draft,...

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