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Crossover designs are an extremely useful tool to investigators, whilst groupsequential methods have proven highly proficient at improving the efficiency ofparallel group trials. Yet, group sequential methods and crossover designs haverarely been paired together. One possible explanation for this could be theabsence of a formal proof of how to strongly control the familywise error ratein the case when multiple comparisons will be made. Here, we provide thisproof, valid for any number of initial experimental treatments and any numberof stages, when results are analysed using a linear mixed model. We thenestablish formulae for the expected sample size and expected number ofobservations of such a trial, given any choice of stopping boundaries. Finally,utilising the four-treatment, four-period TOMADO trial as an example, wedemonstrate group sequential methods in this setting could have reduced thetrials expected number of observations under the global null hypothesis by over33%.

Group Sequential Crossover Trial Designs with Strong Control of the Familywise Error Rate