中国医学伦理学2026，Vol.39Issue(5)：601-608,8.DOI:10.12026/j.issn.1001-8565.2026.05.07
药物临床试验弱势群体保护机制优化
Optimization of protection mechanisms for vulnerable populations in drug clinical trials:a case study of pediatric research participants
摘要
Abstract
Drug clinical trials constitute a critical link in new drug development and an essential means to verify the safety and efficacy of pharmaceuticals.The protection of participants'rights and interests and the prevention of risks directly affect the scientific ethics and social credibility of the trials.Vulnerable groups,due to restricted autonomous decision-making capacities or special social status,are more susceptible to safety risks.Children are a typical representative of vulnerable groups.Their physiological particularities,cognitive limitations,and dependence collectively epitomize the universal protection demands of vulnerable research participants.Taking children as an instance,this paper analyzes the current weak links in the protection of pediatric research participants.Integrating advanced international experience with domestic practical demands,it comprehensively identified protection risk points at every stage and constructed a multi-stakeholder collaborative mechanism for the full-process protection of pediatric research participants.This mechanism incorporated seven main entities,including drug regulatory authorities,sponsors,researchers,and ethics committees,covering the pre-trial,intra-trial,and post-trial phases to meet the requirements of full-chain and multi-dimensional protection.It provided references for the subsequent establishment of a systematic protection mechanism for vulnerable populations.关键词
药物临床试验/儿童研究参与者/多方协同/全流程保护Key words
drug clinical trial/pediatric research participant/multi-stakeholder collaboration/full-process protection分类
医药卫生引用本文复制引用
武广霞,丁传华,李慧,李洪英..药物临床试验弱势群体保护机制优化[J].中国医学伦理学,2026,39(5):601-608,8.基金项目
2025年山东省人文社会科学课题"药物临床试验中弱势群体受试者保护机制优化研究——以儿童受试者为例" （）
