Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations

摘要

Adaptive seamless phase II/III designs combine a phase II and a phase III study into one single confirmatory clinical trial. Several examples of such designs are presented, where the primary endpoint is binary, time-to-event or continuous. The interim adaptations considered include the selection of treatments and the selection of hypotheses related to a pre-specified subgroup of patients. Practical aspects concerning the planning and implementation of adaptive seamless confirmatory studies are also discussed.