Weighted Log-Rank Test for Clinical Trials with Delayed Treatment Effect Based on a Novel Hazard Function Family

Abstract

In clinical trials with delayed treatment effect, the standard log-rank method in testing the difference between survival functions may have problems, including low power and poor robustness, so the method of weighted log-rank test (WLRT) is developed to improve the test performance. In this paper, a hyperbolic-cosine-shaped (CH) hazard function family model is proposed to simulate delayed treatment effect scenarios. Then, based on Fleming and Harrington’s method, this paper derives the corresponding weight function and its regular corrections, which are powerful in test, theoretically. Alternative methods of parameters selection based on potential information are also developed. Further, the simulation study is conducted to compare the power performance between CH WLRT, classical WLRT, modest weighted log-rank test and WLRT with logistic-type weight function under different hazard scenarios and simulation settings. The results indicate that the CH statistics are powerful and robust in testing the late difference, so the CH test is useful and meaningful in practice.