患者报告结局（PRO）作为临床结局疗效评价最重要的指标之一，被广泛用于新药临床试验。在新药临床试验电子化的趋势下，电子化患者报告结局（ePRO）数据采集系统基于其种种可以推进新药临床评价的优势，迎来了快速发展。然而，ePRO在中国仍然处在初期发展阶段，因此将对ePRO的基本概念、功能、国内外临床应用情况及其在新药临床试验疗效评价中的价值等进行介绍；同时总结概括了目前ePRO在我国临床试验应用中存在的问题，最后对ePRO在中国的发展前景进行了探讨。

As one of the most important indicators of clinical outcome, patient-report outcome (PRO) is now widely used in clinical trials of new drugs. Under the trend of electronic clinical trials of new drugs, the electronic patient-report outcome (ePRO) data collection system is developing rapidly, based on the various advantages which can quickly advance the clinical evaluation of new drug. However, ePRO is still in the early stage of development in China. Therefore, this article will introduce the basic concepts, functions, clinical applications of ePRO domestic and overseas, and its value in clinical trials of new drugs. At the same time, it summarized the current problems in the application of ePRO in clinical trials in our state, and finally discussed and looked forward to the development prospects of ePRO in China.

R969.4

国家“重大新药创制”科技重大专项（2017ZX09304002）；上海市卫健委临床研究专项（201940063）；上海市促进市级医院临床技能与临床创新能力三年行动计划项目（20CR4003B）