Inference on Multiple Endpoints in Clinical Trials with Adaptive Interim Analyses

摘要

Planned interim analyses which permit early stopping or sample size adaption of a trial are desirable for ethical and scientific reasons. Multiple test procedures allow inference about several hypotheses within a single clinical trial. In this paper, a method which combines multiple testing with adaptive interim analyses whilst controlling the experimentwise error rate is proposed. The general closed testing principle, the situation of a priori ordered hypotheses, and application of the Bonferroni-Holm method are considered. The practical application of the method is demonstrated by an example.