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Seamless adaptive Phase 2-3 Designs incorporating mid-term design modifications, such as selection of hypotheses or treatment groups, or sample size reestimation during the interim analysis, provide efficient tools to combine the Phase 2 and Phase 3 trials into one. In this presentation, two methods for multiplicity strategy will be introduced for seamless adaptive Phase 2-3 by Sugitani and Bretz (2016) and Jin (2020).
Simulations are conducted to evaluate the performance of power and Type I error and the methods will be illustrated with a confirmatory two-stage adaptive design with a dose selection stage and confirmatory stage with the selected treatment groups.
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