All Times EDT
Keywords: Adaptive design, 2-in-1 trial, seamless design
Seamless adaptive 2-in-1 designs provide possible pathways to expedite drug developments by allowing the expansion of an ongoing Phase 2 trial into a confirmatory Phase 3 trial. Here we present a framework of adaptive 2-in-1 design which can expand an ongoing Phase 2 trial to a confirmatory Phase 3 trial with multiple endpoints or with multiple treatment arms, without inflating the familywise Type I error under a mild assumption.
Simulations will be presented to confirm the control of the familywise Type I error with some illustrative examples.