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带子群选择的两阶段自适应设计置信区间AI 解读

We consider clinical trials in which an experimental treatment is compared with a control in pre-specified patient subpopulations. In such settings, adaptive enrichment designs allow the enrolled population to be modified at an interim analysis, with subpopulations selected according to preplanned rules. Since these interim decisions are data-dependent, valid statistical inference must account for them. We focus on constructing confidence intervals for the treatment effect…

比例风险下限制平均生存时间检验与对数秩检验的效率比较AI 解读

Background: For RCTs with time-to-event endpoints, proportional hazard (PH) models are typically used to estimate treatment effects and logrank tests are commonly used for hypothesis testing. There is growing support for replacing this approach with a model-free estimand and assumption-lean analysis method. One alternative is to base the analysis on the difference in restricted mean survival time (RMST) at a specific time, a single-number summary measure that can be defined…

纳入非同期对照的平台试验治疗比较AI 解读

Shared controls in platform trials comprise concurrent and non-concurrent controls. For a given experimental arm, non-concurrent controls refer to data from patients allocated to the control arm before the arm enters the trial. The use of non-concurrent controls in the analysis is attractive because it may increase the trial's power of testing treatment differences while decreasing the sample size. However, since arms are added sequentially in the trial, randomization occurs…