FDA对研究者在新药和医疗器械临床研究期间安全性报告的要求

FDA requirements for investigators'safety reports during clinical investigation of new drugs and medical devices

上市前药物和医疗器械安全性信息主要来自临床试验,而观察受试者对试验药物和器械反应的是研究者,因此,研究者的不良事件报告至关重要。为帮助研究者确认临床研究期间非预期的安全性信息并遵守安全性报告要求,美国食品药品管理局(FDA)于2021年9月发布了“研究者职责-研究性药物和器械的安全性报告”指导原则(草案),详细说明了对研究者在IND和IDE研究中向申请人和伦理委员会报告的要求。我国目前还没有类似的指导原则,详细介绍FDA的该指导原则,以期对我国新药和新医疗器械研究者在临床研究期间识别非预期的安全信息并按要求及时报告有帮助并对该方面的监管有所启示。

The safety information of drugs and medical devices prior to marketing mainly comes from clinical trials,and it is the investigators who observe the subjects'responses to the investigational drugs and devices.Therefore,adverse event reports from investigators are critically important.To help investigators identify unanticipated safety information during clinical investigation and comply with safety reporting requirements,FDA issued the Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices Guidance for Industry(Draft)in September 2021.The requirements for investigators to report to the sponsors and instituttional review boards in IND and IDE studies are described in detail.At present,there is no similar guidance in China.The guidance of FDA is introduced in detail,which is expected to be helpful for Chinese investigators of new drugs and new medical devices to identify unanticipated safety information during clinical research and report it in time as required,and also to enlighten China's supervision in this regard.