临床研究中的替代结局
摘要
患者可以活得更长、感觉更好或功能更好——这些是直接的、与患者相关的临床结局。1 相比之下，替代终点是旨在预测此类获益的间接指标。它们可用于缩短试验持续时间并使治疗更早可用，但这以更大的不确定性为代价：改善替代指标可能不会改善对患者最终重要的东西。Lo及其同事的一篇关联文章（doi:10.1136/bmj-2026-100618）提出了用于评估单一替代指标相对于临床终点的REASSurE框架。2 该框架通过德尔菲调查、共识会议、试点和最终确定而制定，其透明的方法和报告值得称赞。它提供了一个结构化清单，包含强制或推荐的
English
A patient can live longer, feel better, or function better—these are direct, patient relevant clinical outcomes.1 Surrogate endpoints, in contrast, are indirect measures intended to predict such benefits. They can be used to shorten the duration of trials and make treatments available sooner, but that comes at the cost of greater uncertainty: improving a surrogate may not improve what ultimately matters to patients.A linked article by Lo and colleagues (doi:10.1136/bmj-2026-100618) presents the REASSurE framework for evaluating a single surrogate against a clinical endpoint.2 Developed through a Delphi survey, consensus meeting, piloting, and finalisation, the framework deserves credit for its transparent methods and reporting. It provides a structured checklist of mandatory or recommended