南方医科大学学报2025，Vol.45Issue(5)：1093-1102,10.DOI:10.12122/j.issn.1673-4254.2025.05.23
临床试验中不同转组分析方法的比较
A comparative study of different methods for treatment switching analysis in clinical trials
摘要
Abstract
Objective To compare the commonly used methods for analyzing treatment switching in clinical trials to facilitate selection of optimal methods in different scenarios.Methods Based on the data characteristics of patient conversion in oncology clinical trials,we simulated the survival time of patients across different scenarios and compared the bias,mean square error and coverages of the treatment effects derived from different methods.Results The sample size had an almost negligible impact on the outcomes of the various methods.Compared to conventional methods,more complex methods(RPSFTM,IPCW,TSE,and IPE)resulted in lower errors across different scenarios.The IPCW method could cause a significant increase in errors in cases where the probability of conversion was high.The TSE method had the lowest error and mean squared error when the risk was low and the probability of conversion was high.The IPE method had an obvious advantage in the scenario with a low probability of conversion,but it may slightly underestimate the treatment effect when the inflation factor was small.Conclusion The choice of a specific method for analyzing cohort transition should be made based on considerations of both the probability of conversion and inflation factor in different scenarios.关键词
治疗转组/逆概率删失加权法/秩保持结构失效模型/两阶段估计法/迭代参数估计法Key words
treatment switching/inverse probability censoring weighting/rank preserving structural failure time models/two-stage estimation method/iterative parameter estimation method引用本文复制引用
梁芷玥,徐利珊,李柯柯,于米铼,安胜利..临床试验中不同转组分析方法的比较[J].南方医科大学学报,2025,45(5):1093-1102,10.基金项目
广东省基础与应用基础研究基金(2022A1515012152) （2022A1515012152）
