Division of Urology, University of Ottawa, Ottawa, ON, Canada.
Urol Oncol. 2011 Jul-Aug;29(4):447-53. doi: 10.1016/j.urolonc.2010.06.010.
Clinical trials often report surrogate endpoint data. A surrogate endpoint is a biological marker or clinical sign that can be substituted for a patient-important outcome. Using surrogate endpoints correctly may facilitate and expedite clinical trials and may improve medical decisions. However, rigorous criteria must be met for an endpoint to be considered a valid surrogate. The purpose of this article is to review the topic of surrogate endpoints in the context of a urologic encounter.
临床试验通常会报告替代终点数据。替代终点是一种生物标志物或临床指标,可以替代患者重要的结局。正确使用替代终点可以促进和加快临床试验,并可能改善医疗决策。然而,必须满足严格的标准才能将终点视为有效的替代终点。本文的目的是在泌尿科就诊的背景下审查替代终点的相关问题。