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Abstract

Again, several multiple confirmatory test problems which have already been investigated within the single-stage design are considered with the aim to test both the composite and the most relevant component. In contrast to the single-stage design, the group-sequential and adaptive designs proposed in here are more flexible and thereby allow to address planning uncertainties. When several endpoints are under investigation, as considered in this part of the book, planning uncertainties are of particular relevance, as correct parameter and distribution assumptions for all endpoints are required, and thus the level of uncertainty usually increases compared to a single endpoint problem.

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Rauch, G., Schüler, S., Kieser, M. (2017). Group-Sequential and Adaptive Designs. In: Planning and Analyzing Clinical Trials with Composite Endpoints. Springer Series in Pharmaceutical Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-73770-6_10

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