Randomized clinical trials with time-to-event outcomes have traditionally used the log-rank test followed by the Cox proportional hazards (PH) model to estimate the hazard ratio between the treatment groups. These are valid under the assumption that the right-censoring mechanism is non-informative, i.e. independent of the time-to-event of interest within each treatment group. More generally, the censoring time might depend on additional covariates, and inverse probability of censoring weighting (IPCW) can be used to correct for the bias resulting from the informative censoring. IPCW requires a correctly specified censoring time model conditional on the treatment and the covariates. Doubly robust inference in this setting has not been plausible previously due to the non-collapsibility of the Cox model. However, with the recent development of data-adaptive machine learning methods we derive an augmented IPCW (AIPCW) estimator that has the following doubly robust (DR) properties: it is model doubly robust, in that it is consistent and asymptotic normal (CAN), as long as one of the two models, one for the failure time and one for the censoring time, is correctly specified; it is also rate doubly robust, in that it is CAN as long as the product of the estimation error rates under these two models is faster than root-$n$. We investigate the AIPCW estimator using extensive simulation in finite samples.
翻译:具有时间到活动结果的随机临床试验传统上使用随考克斯比例危害(PH)模型之后的日志测试来估计治疗群体之间的危险比率。这些测试之所以有效,是因为假设右检查机制不具有信息规范性,即独立于每个治疗群体中感兴趣的时间到活动。更一般地说,审查时间可能取决于额外的共差,而审查权重(IPCW)的反概率可用于纠正信息化审查产生的偏差。IPCW要求有一个正确指定的审查时间模型,以治疗和混合体为条件。由于右检查机制是非同步性的,也就是说,每个治疗群体中不受时间到感兴趣的时间到时间到时间;但是,随着最近数据适应机学习方法的发展,我们获得一个强化的IPCW(IPCW)的估测仪,它具有以下两极强的强(DR)特性:它非常坚固,它具有一致性和耐受约束的时间模型(CAN),在这个环境中,一个稳健的汇率是双级的汇率。