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协变量调整的限制平均生存时间群序贯比较AI 解读

The restricted mean survival time (RMST) is the mean survival time in the study population followed up to a specific time point, and is simply the area under the survival curve up to the specific time point. The difference between two RMSTs quantifies the group difference in a time scale by measuring the integrated difference between survival curves in the two treatment groups. This paper develops a group sequential (GS) test of comparing two RMSTs up to a restriction time…

协变量调整的生存概率组序贯比较AI 解读

In confirmatory clinical trials, survival outcomes are frequently studied and interim analyses for efficacy and/or futility are often desirable. Methods such as the log rank test and Cox regression model are commonly used to compare treatments in this setting. They rely on a proportional hazards (PH) assumption and are subject to type I error rate inflation and loss of power when PH are violated. Such violations may be expected a priori, particularly when the mechanisms of…