Adaptive designs require pre-specification in the protocol and statistical analysis plan to preserve type I error and trial integrity. FDA guidance (Adaptive Designs for Clinical Trials of Drugs and Biologics) describes acceptable adaptations and the information sponsors should submit.
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Glossary Term
Adaptive Trial
Study Design
Also known as: adaptive design, adaptive clinical trial
A trial design that allows pre-planned modifications based on accumulating data, such as dose adjustment, sample size re-estimation, or dropping arms.
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