中国食品药品监管Issue(3)：44-69,26.DOI:10.3969/j.issn.1673-5390.2025.03.005
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 Phase Ⅰ Clinical Trials
摘要
Abstract
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Key words
phase I clinical trials/healthy participants/safety management/risk control/strategy分类
药学引用本文复制引用
杨海静,赵琳,杨玲,陈锐,张菁,李海燕,郑莉,韩晓红..Ⅰ期临床试验中健康参与者安全性管理的专家共识[J].中国食品药品监管,2025,(3):44-69,26.基金项目
国家"重大新药创制"科技重大专项资助项目(2017ZX09304005) （2017ZX09304005）
上海市科技创新行动计划(22S11904102) （22S11904102）
