藥物安全性問題是重要的公共健康問題，貫穿于新藥研發(fā)的整個(gè)生命周期，在藥物上市前及時(shí)發(fā)現(xiàn)潛在的不安全因素，充分評(píng)價(jià)藥物安全性將有助于藥品監(jiān)管機(jī)構(gòu)權(quán)衡獲益與風(fēng)險(xiǎn)并盡早作出批準(zhǔn)決定。因此，不斷加強(qiáng)藥物安全性監(jiān)測(cè)工作，持續(xù)警戒藥品風(fēng)險(xiǎn)信號(hào)，把握藥品安全生命線，維護(hù)人民群眾權(quán)益，是新藥臨床試驗(yàn)中的關(guān)注重點(diǎn)。梳理藥物臨床試驗(yàn)安全性評(píng)價(jià)工作中存在的問題并提出改進(jìn)建議，以期為藥物臨床試驗(yàn)各方提供參考。

Drug safety is an important public health issue for people's livelihood, which runs through the whole life cycle of new drug research and development. Timely detection of potential unsafe factors before drug launch and full evaluation of drug safety will help drug regulatory authorities weigh benefits and risks and make approval decisions as soon as possible. Therefore, it is the focus of attention in clinical trials of new drugs to continuously strengthen drug safety monitoring, continuously alert drug risk signals, grasp the lifeline of drug safety, and safeguard the rights and interests of the people. This article starts from the problems existing in the safety evaluation of drug clinical trials and puts forward suggestions for improvement in order to provide reference for all parties in clinical trials.

上海市“科技創(chuàng)新行動(dòng)計(jì)劃”生物醫(yī)藥科技支撐專項(xiàng)（20S21902100）；上海市慢性筋骨病臨床醫(yī)學(xué)研究中心項(xiàng)目（20MC1920600）；上海市教委協(xié)同創(chuàng)新中心項(xiàng)目（A1-U21-205-0103）；上海市申康中心示范性研究型病房建設(shè)（SHDC2022CRW010）；上海市申康中心醫(yī)企融合創(chuàng)新協(xié)同專項(xiàng)（SHDC2022CRT018）