On group sequential tests for data in unequally sized groups and with unknown variance

Abstract

Abstract We present a method to generalise the scope of application of group sequential tests designed for equally sized groups of normal observations with known variance. Preserving the significance levels against which standardised statistics are compared leads to tests for unequally grouped data which maintain Type I error probabilities to a high degree of accuracy. The same approach can be followed when observations have unknown variance by setting critical values for Studentised statistics at percentiles of the appropriate t -distributions. This significance level approach is equally applicable to group sequential one-sided tests and two-sided tests, possibly with early stopping permitted to accept the null hypothesis. In applications to equivalence testing, tests are required to maintain a specified power, rather than Type I error rate: such tests can be constructed by defining the standardised test statistics used in the significance level approach with respect to appropriately chosen hypotheses.