Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (eBook, PDF)

Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (eBook, PDF)

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This book provides an up-to-date review of the general principles and techniques of confirmatory adaptive designs, a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop a trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection, or a selection of a pre-specified sub-population. First introduced in the 1990s, this popular...

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