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Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: Applications and Practical Considerations
Author(s) -
Schmidli Heinz,
Bretz Frank,
Racine Amy,
Maurer Willi
Publication year - 2006
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200510231
Subject(s) - interim , selection (genetic algorithm) , interim analysis , computer science , clinical endpoint , phase (matter) , clinical trial , confirmatory factor analysis , event (particle physics) , binary number , operations research , econometrics , reliability engineering , psychology , medical physics , medicine , artificial intelligence , mathematics , machine learning , structural equation modeling , engineering , political science , chemistry , arithmetic , physics , organic chemistry , quantum mechanics , law
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. (© 2006 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)