Basket Trials Design

Basket trials test a therapeutic intervention for several different disease indications simultaneously in the same clinical trial. Indications are grouped together in a basket because they share a molecular marker or a disease mechanism believed to be predictive of clinical benefit from the therapeutic intervention under study. Basket trials are a type of master protocol, a class of clinical designs that investigate several hypotheses concurrently. Master protocols include basket trials, whereby one therapy is tested in multiple indications; umbrella trials, whereby multiple therapies are tested in one indication; and platform trials, whereby multiple therapies enter and exit an ongoing study in an assembly-line fashion.

This entry summarizes the motivation for using master protocols, metrics for basket trial performance evaluation, advantages and limitations of basket trials, and ...

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