Stablein D M, Carter W H, Novak J W
Control Clin Trials. 1981 Jun;2(2):149-59. doi: 10.1016/0197-2456(81)90005-2.
The log-rank test or the proportional hazard model is a valuable, widely accepted method for analyzing time-to-response data from comparative clinical trials. When the hazard ratio is constant in time, this procedure is optimal. Indiscriminate or unthinking use of this approach results in problems in the determination of treatment differences. For example, when the true survival curves intersect, the hazard ratio cannot be constant, i.e., the hazard functions are not proportional. It is shown that by considering time-by-treatment interactions we gain flexibility in describing the relationships among hazard functions. In this paper we demonstrate with the results of a clinical trial how available methodology can be used to permit tests for the appropriateness of the model and to enable informative analysis of such data.
对数秩检验或比例风险模型是一种有价值且被广泛接受的方法，用于分析来自比较临床试验的反应时间数据。当风险比在时间上恒定时，此方法是最优的。不加区分或盲目使用这种方法会在确定治疗差异时产生问题。例如，当真实生存曲线相交时，风险比不可能恒定，即风险函数不成比例。结果表明，通过考虑时间与治疗的交互作用，我们在描述风险函数之间的关系时获得了灵活性。在本文中，我们通过一项临床试验的结果证明了如何使用现有方法来检验模型的适用性，并对这类数据进行有意义的分析。
