摘要肿瘤临床试验中，缓解持续时间（DOR）因仅纳入缓解者分析，存在选择偏倚并违背了随机化原则。为克服这一局限，本文介绍了限制平均反应持续时间（RMDOR）这一新型复合疗效指标的应用价值。本文系统阐述了RMDOR的定义、参数估计及假设检验方法，并结合“PBIR”软件包对一项非小细胞肺癌Ⅲ期临床试验数据进行了实例分析。RMDOR能够在意向性分析人群层面同时整合客观缓解率、起效时间和DOR的信息，有效弥补单一终点的不足。实例分析结果显示，RMDOR可对不同治疗方案的疗效差异进行稳定而合理的量化评估。RMDOR为肿瘤临床试验提供了一种新的方法学工具，能够在保持意向性治疗随机化优势的同时，综合反映治疗获益，建议在实际研究中与传统终点联合应用。

abstractsIn oncology clinical trials, the duration of response (DOR) is limited by the inclusion of only responders, leading to selection bias and violating the principle of randomization. To address this limitation, this study introduces the restricted mean duration of response (RMDOR) as a novel composite efficacy endpoint. The definition, parameter estimation, and hypothesis testing procedures of RMDOR were systematically described, and an example analysis was conducted using data from a phase Ⅲ non-small cell lung cancer clinical trial with the package "PBIR". RMDOR integrates information from the objective response rate, time to response, and DOR at the intention-to-treat population level, effectively compensating for the limitations of single endpoints. The example analysis demonstrated that RMDOR provides a stable and rational quantification of treatment differences between therapeutic regimens. RMDOR offers a new methodological tool for oncology trials that preserves the advantages of randomization under the intention-to-treat principle while comprehensively reflecting treatment benefits. Its combined use with traditional endpoints is recommended in future clinical studies.