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

Draft guidance specifies documentation that must be submitted to FDA prior to conducting an adaptive trial, and what to include in an application.

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The US FDA's new draft guidance on clinical trial adaptive designs lists the information sponsors must submit to the agency before initiating a trial and what data they should include in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The agency issued the draft guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics, on Sept. 28.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...

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