The Cox proportional hazards model, commonly used in clinical trials, assumes proportional hazards. However, it does not hold when, for example, there is a delayed onset of the treatment effect. In such a situation, an acute change in the hazard ratio function is expected to exist. This paper considers the Cox model with change-points and derives AIC-type information criteria for detecting those change-points. The change-point model does not allow for conventional statistical asymptotics due to its irregularity, thus a formal AIC that penalizes twice the number of parameters would not be analytically derived, and using it would clearly give overfitting analysis results. Therefore, we will construct specific asymptotics using the partial likelihood estimation method in the Cox model with change-points. Based on the original derivation method for AIC, we propose information criteria that are mathematically guaranteed. If the partial likelihood is used in the estimation, information criteria with penalties much larger than twice the number of parameters could be obtained in an explicit form. Numerical experiments confirm that the proposed criterion is clearly superior in terms of the original purpose of AIC, which is to provide an estimate that is close to the true structure. We also apply the proposed criterion to actual clinical trial data to indicate that it will easily lead to different results from the formal AIC.
翻译:临床试验中常用的考克斯比例危害模型假定了相称的危害。然而,它并不能够维持,例如,治疗效应的延迟开始时间。在这种情况下,危险比率功能预计将发生剧烈变化。本文件考虑考克斯模型,带有变化点,并得出了用于检测这些变化点的AIC型信息标准。改变点模型不允许传统的统计性症状,因为其不规则性,因此,正式的ACIC对参数数进行两倍的处罚不会通过分析得出,而使用它显然会产生过大的分析结果。因此,我们将使用Cox模型中带有变化点的部分可能性估计方法来建立具体的测试性。根据AIC最初的推算方法,我们提出了在数学上得到保证的信息标准。如果在估算中使用部分可能性,则可以以明确的形式获得比参数数高出一倍以上的惩罚性信息标准。数字实验证实,拟议的标准在AIC最初目的方面显然优于以上,因此,我们将使用带有变化点的Cox模型中部分可能性估计方法。根据AIC的原始估计方法,我们提出一个比较容易的临床试验结果,我们还将提出一个比较的模型。