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. 2006 Aug;48(4):635-43.
doi: 10.1002/bimj.200510231.

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

Heinz Schmidli  1 , Frank Bretz, Amy Racine, Willi Maurer
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Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations

Heinz Schmidli et al. Biom J. 2006 Aug.

Abstract

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.

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