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利用协变量调整伪值回归提高限制平均生存时间估计精度AI 解读

Covariate adjustment is desired by both practitioners and regulators of randomized clinical trials because it improves precision for estimating treatment effects. However, covariate adjustment presents a particular challenge in time-to-event analysis. We propose to apply covariate adjusted pseudovalue regression to estimate between-treatment difference in restricted mean survival times (RMST). Our proposed method incorporates a prognostic covariate to increase precision of…

利用分层对二元结局进行预后协变量调整AI 解读

Covariate adjustment and methods of incorporating historical data in randomized clinical trials (RCTs) each provide opportunities to increase trial power. We unite these approaches for the analysis of RCTs with binary outcomes based on the Cochran-Mantel-Haenszel (CMH) test for marginal risk ratio (RR). In PROCOVA-CMH, subjects are stratified on a single prognostic covariate reflective of their predicted outcome on the control treatment (e.g. placebo). This prognostic score…