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tteICE: An R Package for Estimating Treatment Effects on Time-to-Event Outcomes with Intercurrent Events in Two-Arm Trials

tteICE:估计两组试验中伴随中间事件的事件时间处理效应的 R 包

Evaluating treatment effects in clinical trials with time-to-event outcomes is complicated by intercurrent events (ICEs), e.g., treatment discontinuation or competing events. While the ICH E9 (R1) addendum outlines five strategies to address these challenges, accessible software implementing these methods is limited. This article introduces the \pkg{tteICE} package for \proglang{R}, which implements five strategies to facilitate valid causal inference in the presence of…

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Inference for Cumulative Incidences and Treatment Effects in Randomized Controlled Trials with Time-to-Event Outcomes under ICH E9 (R1)

ICH E9(R1)框架下随机试验累积发生率与处理效应的推断

In randomized controlled trials (RCTs) that focus on time-to-event outcomes, intercurrent events can arise in two ways: as semi-competing events, which modify the hazard of the primary outcome events, or as competing events, which make the definition of the primary outcome events unclear. Although five strategies have been proposed in the ICH E9 (R1) addendum to address intercurrent events in RCTs, these strategies are not easily applicable to time-to-event outcomes when…

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Propensity score regression for causal inference with treatment heterogeneity

用于异质性治疗效应因果推断的倾向得分回归

Understanding how treatment effects vary on individual characteristics is critical in the contexts of personalized medicine, personalized advertising and policy design. When the characteristics are of practical interest are only a subset of full covariate, non-parametric estimation is often desirable; but few methods are available due to the computational difficult. Existing non-parametric methods such as the inverse probability weighting methods have limitations that hinder…

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