A Comparison of Statistical Methods for Time-To-Event Analyses in Randomized Controlled Trials Under Non-Proportional Hazards.

ABSTRACT: While well-established methods for time-to-event data are available when the proportional hazards assumption holds, there is no consensus on the best inferential approach under non-proportional hazards (NPH). However, a wide range of parametric and non-parametric methods for testing and estimation in this scenario have been proposed. To provide recommendations on the statistical analysis of clinical trials where non-proportional hazards are expected, we conducted a simulation study under different scenarios of non-proportional hazards, including delayed onset of treatment effect, crossing hazard curves, subgroups with different treatment effects, and changing hazards after disease progression. We assessed type I error rate control, power, and confidence interval coverage, where applicable,

SUBMITTER: Klinglmuller F 

PROVIDER: S-EPMC11840476 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature