ABSTRACT

For the equivalence trial with survivor outcomes from two treatment groups, the most popular testing procedure is the extension of log-rank test under proportional hazards (PH) model. In literature, an alternative test has been proposed under the proportional odds (PO) survival model. In practice, both PH and PO hazards assumptions can be violated. One alternative is the log transformation model other than the PH or PO models. Another alternative model is the partly Aalen’s additive risk model which allows the influence of some covariates to vary over time. In this article, we propose equivalence tests for the difference of two survival functions under the class of log transformation model and that of two cumulative hazard functions under the partly Aalen’s model. Simulation studies demonstrate that the proposed tests perform well in finite samples.

摘要

对于来自两个治疗组的幸存者结果的等效性试验，最流行的测试程序是在比例风险 (PH) 模型下扩展对数秩检验。在文献中，在比例优势 (PO) 生存模型下提出了一种替代测试。在实践中，可能会违反 PH 和 PO 危害假设。一种替代方法是对数转换模型，而不是 PH 或 PO 模型。另一种替代模型是部分 Aalen 的加性风险模型，它允许一些协变量的影响随时间变化。在本文中，我们提出了对数转换模型类下的两个生存函数的差异和部分Aalen模型下的两个累积风险函数的差异的等价检验。