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亚组治疗效应的贝叶斯收缩方法：统一实现与比较AI 解读

Evaluating treatment effect heterogeneity across patient subgroups is a fundamental aspect of clinical trial analysis. These analyses have inherent limitations due to small sample sizes and the substantial number of subgroups investigated. There is a tendency to focus on extreme estimates, which may reflect random variation rather than true effects, potentially leading to spurious clinical conclusions. Statisticians in regulatory agencies and pharmaceutical companies have…

纳入部分伴发事件后观测的临床试验因果参考模型贝叶斯分析AI 解读

When treatment policy estimands are of interest, clinical trials often attempt to collect patient data after intercurrent events (ICEs), although such data are often limited. Retrieved dropout imputation methods, which use pre-ICE and available post-ICE data to impute missing post-ICE outcomes, are commonly applied but often yield treatment effect estimates with large standard errors (SEs) and may encounter convergence issues when post-ICE data are sparse. Reference-based…

临床试验缺失数据的因果参照模型贝叶斯分析AI 解读

The statistical analysis of clinical trials is often complicated by missing data. Patients sometimes experience intercurrent events (ICEs), which usually (although not always) lead to missing subsequent outcome measurements for such individuals. The reference-based imputation methods were proposed by Carpenter et al. (2013) and have been commonly adopted for handling missing data due to ICEs when estimating treatment policy strategy estimands. Conventionally, the variance…

用收缩方法估计生存终点随机试验中重叠亚组的治疗效应AI 解读

In randomized controlled trials, forest plots are frequently used to investigate the homogeneity of treatment effect estimates in subgroups. However, the interpretation of subgroup-specific treatment effect estimates requires great care due to the smaller sample size of subgroups and the large number of investigated subgroups. Bayesian shrinkage methods have been proposed to address these issues, but they often focus on disjoint subgroups while subgroups displayed in forest…

标准与参照组条件均值插补AI 解读

Clinical trials with longitudinal outcomes typically include missing data due to missed assessments or structural missingness of outcomes after intercurrent events handled with a hypothetical strategy. Approaches based on Bayesian random multiple imputation and Rubin's rule for pooling results across multiple imputed datasets are increasingly used in order to align the analysis of these trials with the targeted estimand. We propose and justify deterministic conditional mean…