Case Study for a Two Stage Adaptive Seamless Phase IIb/III Confirmatory Design
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*Jeffrey Maca, Novartis Pharmaceuticals 

Keywords: adaptive, seamless II/III, confirmatory

There has been much work in the statistical community as well as the pharmaceutical community to develop the methodology needed for implementation of seamless Phase II/III designs. Some of the rewards for these efforts are now being realized as adaptive designs are beginning to be implemented across the industry. This case study is one example of a study which was designed from the beginning as a seamless phase II/III study, and also planned to be one of the pivotal trials used for registration of a new chemical entity. A description of the design and methodology used in the study, as well as the progress of the study, will be given.