In this chapter, we provide an overview of the fundamental concepts and technical details for group-sequential designs for clinical trials comparing two interventions based on two primary endpoints. In this situation, there are many procedures for controlling the Type I error rate. We discuss the simplest procedure, i.e., the weighted Bonferroni procedure which is commonly applied in practice. We evaluate the behavior of the sample size, power, and Type I error rate associated with the procedure.
Average sample size Efficacy stopping Lan–DeMets error-spending method Maximum sample size Recycled significance level Union–intersection test Weighted Bonferroni procedure
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