In assessing Overall Survival (OS) in oncology studies, it is essential for the efficacy measure to be Logic-respecting, for otherwise patients may be incorrectly targeted. This paper explains, while Time Ratio (TR) is Logic-respecting, Hazard Ratio (HR) is not Logic-respecting. With Time Ratio (TR) being recommended, a smooth transitioning strategy is suggested. The conclusion states: Logicality requires, and Subgroup Mixable Estimation (SME) delivers, an efficacy assessment for the overall population within the range of minimum and maximum efficacy in the subgroups, no matter how outcome is measured, whichever logic-respecting efficacy measure is chosen, the same efficacy assessment regardless of how subgroups are stratified.
翻译:在肿瘤学研究中评估总生存期(OS)时,疗效指标必须满足逻辑一致性要求,否则患者可能被错误地设定为目标人群。本文阐释了时间比(TR)具有逻辑一致性,而风险比(HR)则不具备。在推荐采用时间比(TR)的基础上,本文提出了一种平滑过渡策略。结论指出:无论采用何种结局测量方式、选择何种符合逻辑一致性的疗效指标、或如何进行亚组分层,逻辑性要求——且亚组可混合估计(SME)方法能够实现——对总体人群的疗效评估应处于各亚组疗效的最小值与最大值之间,并确保亚组分层方式不会改变疗效评估结果。