Ⅰ期临床试验中健康参与者安全性管理的专家共识  

Expert Consensus on Safety Management of Healthy Participants in PhaseⅠClinical Trials

作　　者：杨海静[1] 赵琳[2] 杨玲 陈锐[4] 张菁[1] 李海燕[2] 郑莉 韩晓红 YANG Hai-jing;ZHAO Lin;YANG Ling;CHEN Rui;ZHANG Jing;LI Hai-yan;ZHENG Li;HAN Xiao-hong(Huashan Hospital,Fudan University;Peking University Third Hospital;West China Hospital,Sichuan University;Peking Union Medical College Hospital)

机构地区：[1]复旦大学附属华山医院 [2]北京大学第三医院 [3]四川大学华西医院 [4]中国医学科学院北京协和医院

出　　处：《中国食品药品监管》2025年第3期44-69,共26页China Food & Drug Administration Magazine

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09304005);上海市科技创新行动计划(22S11904102)。

摘　　要：随着我国药品审评审批制度的不断完善和临床试验国际化进程的加快,I期临床试验中健康参与者的安全性管理成为一项关键挑战。为应对这一需求,本共识基于国内多家资深临床试验机构及申办方的实践经验,结合《药物临床试验不良事件相关性评价技术指导原则(试行)》、国内外相关法规及标准等,提出了一套系统性的健康参与者安全性管理策略。本共识重点涵盖健康参与者的定义及筛选入组标准、给药后安全性评价,以及方案设计和实施中的安全性风险管控措施等内容。通过总结实践经验与优化管理方法,本共识旨在规范健康参与者的安全管理流程,提升I期临床试验的安全性和科学性,为国内外同行提供参考。With the continuous improvement of China's drug review and approval system and the acceleration of clinical trial internationalization,the safety management of healthy participants in phase I clinical trials has become a critical challenge.In response,this consensus draws on the practical experience of multiple leading domestic clinical trial institutions and sponsors,incorporating the Technical Guidelines for the Causality Assessment of Adverse Events in Drug Clinical Trials(Provisional)and relevant domestic and international regulations and standards,to propose a systematic safety management strategy for healthy participants.This consensus focuses on the definition and screening criteria for healthy participants,post-dosing safety evaluation,and safety risk management measures in protocol design.By summarizing practical experiences and optimizing management approaches,this consensus aims to standardize the safety management processes for healthy participants,enhance the safety and scientific rigor of phase I clinical trials,and provide a reference for both domestic and international peers.

关 键 词：I期临床试验 健康参与者 安全性管理 风险管控 策略 

分 类 号：R95[医药卫生—药学]