Testing and estimation in flexible group sequential designs with adaptive treatment selection.
Integrating selection and confirmation phases into a single trial can expedite the development of new treatments and allows to use all accumulated data in the decision process. In this paper we review adaptive treatment selection based on combination tests and propose overall adjusted p-values and simultaneous confidence intervals. Also point estimation in adaptive trials is considered. The methodology is illustrated in a detailed example based on an actual planned study.
Posch
Martin
M
Section of Medical Statistics, Core Unit for Medical Statistics and Informatics, Medical University of Vienna, Spitalgasse 23, A-1090 Wien, Austria. martin.posch@meduniwien.ac.at
Koenig
Franz
F
Branson
Michael
M
Brannath
Werner
W
Dunger-Baldauf
Cornelia
C
Bauer
Peter
P
D001317:Austria; D002986:Clinical Trials as Topic; D016001:Confidence Intervals; D006801:Humans; D015233:Models, Statistical; D012107:Research Design; D035703:Therapies, Investigational / Q000706:statistics & numerical data*