患者報告結(jié)局（PRO）作為臨床結(jié)局療效評價最重要的指標(biāo)之一，被廣泛用于新藥臨床試驗。在新藥臨床試驗電子化的趨勢下，電子化患者報告結(jié)局（ePRO）數(shù)據(jù)采集系統(tǒng)基于其種種可以推進(jìn)新藥臨床評價的優(yōu)勢，迎來了快速發(fā)展。然而，ePRO在中國仍然處在初期發(fā)展階段，因此將對ePRO的基本概念、功能、國內(nèi)外臨床應(yīng)用情況及其在新藥臨床試驗療效評價中的價值等進(jìn)行介紹；同時總結(jié)概括了目前ePRO在我國臨床試驗應(yīng)用中存在的問題，最后對ePRO在中國的發(fā)展前景進(jìn)行了探討。

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

國家“重大新藥創(chuàng)制”科技重大專項（2017ZX09304002）；上海市衛(wèi)健委臨床研究專項（201940063）；上海市促進(jìn)市級醫(yī)院臨床技能與臨床創(chuàng)新能力三年行動計劃項目（20CR4003B）