Adaptive Trials Could Have A Steep Regulatory Learning Curve
Sponsors should take care that drug development efficiencies gained with the advent of adaptive clinical trials aren't offset by lack of opportunity to reflect on data from one trial to the next and "design a thoughtful, complete program," FDA warns in its draft guidance for adaptive trial design
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Draft guidance specifies documentation that must be submitted to FDA prior to conducting an adaptive trial, and what to include in an application.
Agency plans to issue 102 new and revised draft guidances this year, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and ANDA refuse-to-receive standards.
FDA’s centers may slingshot development work on how best to use control data.