关键词: 替代终点, 替代指标, 主要结局, 随机对照试验, 临床试验

Abstract: Surrogate endpoints are frequently used to substitute for target outcomes in randomized controlled trials to shorter trial duration, reduced sample size and etc. But some surrogate endpoints would increase uncertainty of the intervention’s true effect and unreliable in revealing intervention harms. We do need better reporting of trials that rely on surrogate endpoints. The SPIRIT-Surrogate and CONSORT- Surrogate provides the minimum reporting requirements for trials that use surrogate endpoints. Those extension checklists help to improve transparency, usefulness of trial findings, and ultimately reduce research waste. We interpreted these two guidelines with the aim of providing reference for practitioners and drawing their attention to surrogate endpoints.

Key words: Surrogate endpoints, Surrogate indicators, Primary outcomes, Randomized controlled trials, Clinical trials