药物安全性问题是重要的公共健康问题，贯穿于新药研发的整个生命周期，在药物上市前及时发现潜在的不安全因素，充分评价药物安全性将有助于药品监管机构权衡获益与风险并尽早作出批准决定。因此，不断加强药物安全性监测工作，持续警戒药品风险信号，把握药品安全生命线，维护人民群众权益，是新药临床试验中的关注重点。梳理药物临床试验安全性评价工作中存在的问题并提出改进建议，以期为药物临床试验各方提供参考。

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“科技创新行动计划”生物医药科技支撑专项（20S21902100）；上海市慢性筋骨病临床医学研究中心项目（20MC1920600）；上海市教委协同创新中心项目（A1-U21-205-0103）；上海市申康中心示范性研究型病房建设（SHDC2022CRW010）；上海市申康中心医企融合创新协同专项（SHDC2022CRT018）