Covariate-Adjusted Group Sequential Comparisons of Survival Probabilities.

ABSTRACT: In confirmatory clinical trials, survival outcomes are frequently studied and interim analyses for efficacy and/or futility are often desirable. Methods including the log rank test and Cox regression model are commonly used for treatment comparisons, but are most efficient in a proportional hazards (PH) setting and are subject to a loss of power when PH are violated. Such violations may be expected a priori, particularly when the mechanisms of treatments differ such as immunotherapy versus chemotherapy for treating cancer. We propose group sequential tests for comparing survival probabilities with covariate adjustment that allow for interim analyses in the presence of non-PH and offer easily interpreted, clinically meaningful summary measures of the treatment effect. The joint distribution

SUBMITTER: Zhang P 

PROVIDER: S-EPMC12822512 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature