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肿瘤临床试验中非比例风险下的单样本生存检验AI 解读

In oncology, conduct well-powered time-to-event randomized clinical trials may be challenging due to limited patietns number. Many designs for single-arm trials (SATs) have recently emerged as an alternative to overcome this issue. They rely on the (modified) one-sample log-rank test (OSLRT) under the proportional hazards to compare the survival curves of an experimental and an external control group. We extend Finkelstein's formulation of OSLRT as a score test by using a…

利用伪观测进行协变量调整的限制平均生存时间贝叶斯分析AI 解读

The difference in restricted mean survival time (RMST) is a clinically meaningful measure to quantify treatment effect in randomized controlled trials, especially when the proportional hazards assumption does not hold. Several frequentist methods exist to estimate RMST adjusted for covariates based on modeling and integrating the survival function. A more natural approach may be a regression model on RMST using pseudo-observations, which allows for a direct estimation…