Abstract
In order to apply group sequential methods for interim analysis for early stopping in clinical trials, the joint distribution of test statistics over time has to be known. Often the distribution is multivariate normal or asymptotically so, and an application of group sequential methods requires multivariate integration to determine the group sequential boundaries. However, if the increments between successive test statistics are independent, the multivariate integration reduces to a univariate integration involving simple recursion based on convolution. This allows application of standard group sequential methods. In this paper we review group sequential methods and the development that established independent increments in test statistics for the primary outcomes of longitudinal or failure time data.
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(c) SORT-Statistics and Operations Research Transactions, 2020