Log-rank and stratified log-rank tests

Abstract

In randomized clinical trials with right-censored time-to-event outcomes, the popular log-rank test without adjusting for baseline covariates is asymptotically valid for treatment effect under simple randomization of treatments but is too conservative under covariate-adaptive randomization. The stratified log-rank test, which adjusts baseline covariates in the test procedure by stratification, is asymptotically valid regardless of what treatment randomization is applied. In the literature, however, under simple randomization there is no affirmative conclusion about whether the stratified log-rank test is asymptotically more powerful than the unstratified log-rank test. In this article we show when the stratified and unstratified log-rank tests aim for the same null hypothesis and that, under simple randomization, the stratified log-rank test is asymptotically more powerful than the unstratified log-rank test in the region of alternative hypothesis that is specified by a Cox proportional hazards model. We also provide some discussion about why we do not have an affirmative conclusion in general.

Keywords:

• Baseline covariates
• covariate-adaptive randomization
• null hypothesis of no treatment effect
• Pitman's relative efficiency
• time-to-event
• validity of tests

Acknowledgements

We would like to thank two anonymous referees and an associate editor for helpful comments and suggestions.

Disclosure statement

No potential conflict of interest was reported by the author(s).