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Bias reduction in g-computation for covariate adjustment in randomized clinical trials

随机临床试验中协变量调整 g-computation 的偏差减少

G-computation is a powerful method for estimating unconditional treatment effects with covariate adjustment in randomized clinical trials. It typically relies on fitting canonical generalized linear models. However, this could be problematic when the sample size or event number is small relative to the number of covariates. Common issues include the underestimation of the variance and the potential nonexistence of maximum likelihood estimators. Bias reduction methods are…

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Collaborative Indirect Treatment Comparisons with Multiple Distributed Single-arm Trials

多个分布式单臂试验的协作间接治疗比较

When randomized controlled trials are impractical or unethical to simultaneously compare multiple treatments, indirect treatment comparisons using single-arm trials offer valuable evidence for health technology assessments, especially for rare diseases and early-phase drug development. In practice, each sponsor conducts a single-arm trial on its own drug with restricted data-sharing and targets effects in its trial population, which can lead to unfair comparisons. This…

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A robust score test in g-computation for covariate adjustment in randomized clinical trials leveraging different variance estimators via influence functions

随机临床试验协变量调整中基于影响函数方差的稳健 g 计算得分检验

G-computation has become a widely used robust method for estimating unconditional (marginal) treatment effects with covariate adjustment in the analysis of randomized clinical trials. Statistical inference in this context typically relies on the Wald test or Wald interval, which can be easily implemented using a consistent variance estimator. However, existing literature suggests that when sample sizes are small or when parameters of interest are near boundary values,…

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Causally-interpretable meta-analysis: clearly-defined causal effects and two case studies

具有因果解释的元分析:明确的因果效应与两个案例

Meta-analysis is commonly used to combine results from multiple clinical trials, but traditional meta-analysis methods do not refer explicitly to a population of individuals to whom the results apply and it is not clear how to use their results to assess a treatment's effect for a population of interest. We describe recently-introduced causally-interpretable meta-analysis methods and apply their treatment effect estimators to two individual-participant data sets. These…

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