Abstract
In this chapter, the test problem is introduced for the case of a standard single-stage design, meaning that no interim analysis is performed. The underlying parameters and distributional assumptions, the test problems, and the test statistics will be separately formulated for (composite) binary endpoints and for (composite) time-to-(first-)event endpoints. Moreover, approaches to calculate the required sample size are provided.
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Rauch, G., Schüler, S., Kieser, M. (2017). The Single-Stage Design. 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_5
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DOI: https://doi.org/10.1007/978-3-319-73770-6_5
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