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Group sequential designs in clinical trials allow for interim efficacy andfutility monitoring. Adjustment for baseline covariates can increase power andprecision of estimated effects. However, inconsistently applying covariateadjustment throughout the stages of a group sequential trial can result ininflation of type I error, biased point estimates, and anti-conservativeconfidence intervals. We propose methods for performing correct interimmonitoring, estimation, and inference in this setting that avoid these issues.We focus on two-arm trials with simple, balanced randomization and continuousoutcomes. We study the performance of our boundary, estimation, and inferenceadjustments in simulation studies. We end with recommendations about theapplication of covariate adjustment in group sequential designs.

Accounting for Inconsistent Use of Covariate Adjustment in Group Sequential Trials