Group sequential clinical trial designs for normally distributed outcome variables.

In a group sequential clinical trial, accumulated data are analyzed at numerous time points to allow early decisions about a hypothesis of interest. These designs have historically been recommended for their ethical, administrative, and economic benefits. In this article, we first discuss a collection of new commands for computing the stopping boundaries and required group size of various classical group sequential designs, assuming a normally distributed outcome variable. Then, we demonstrate how the performance of several designs can be compared graphically.