Adaptive Trials Guidance For Pediatric Drugs Will Draw On Device Advice
FDA’s centers may slingshot development work on how best to use control data.
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Basket trials like NCI-MATCH could show the value of adaptive clinical trial designs based on advanced Bayesian statistics, furthering a goal of the 21st Century Cures draft legislation.
Adaptive device clinical trials, where study is designed in anticipation of midstream changes, are the focus on a new FDA draft guidance. Adaptive trials can reduce the duration and cost of a study without undermining its integrity, but the practice should be applied with caution, FDA says.
Advisory committee encourages studies with young children in the disease; emphasis on research as a safety tool could have broader policy implications.