儿童药物临床试验的受试者保护问题研究——基于伦理审查视角  

Study on subject protection in clinical trials of pediatric drugs:from the perspective of ethical review

作　　者：方中坚 沈家辉 王彩依 杜沛龙 汪颖霞 朱思琪 邵明立[2] 樊玉录 FANG Zhong-jian;SHEN Jia-hui;WANG Cai-yi;DU Pei-long;WANG Ying-xia;ZHU Si-qi;SHAO Ming-li;FAN Yu-lu(Shanghai University of Medicine&Health Sciences,Shanghai 201318,China;China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]上海健康医学院药学院,上海201318 [2]中国药科大学,南京211198

出　　处：《中国新药杂志》2024年第18期1927-1932,共6页Chinese Journal of New Drugs

基　　金：上海健康医学院2023年科研骨干校外学术导师制项目(AMSCP-23-07-01);国家自然科学基金资助项目(81860179);上海市教委教师发展工程产学研践习-上海交通大学项目(A1-2601-19-311219)。

摘　　要：儿童是一类敏感的特殊群体,其身心状况与成人有着显著的不同。儿童药物临床试验的开展需要考虑到的因素众多。我国儿童药物临床试验体系尚处于萌芽阶段,存在一些不成熟的地方,这可能会威胁到受试者的安全与权益。本研究根据儿童临床试验的特点,结合儿童作为特殊受试者群体的权益保护需求,就知情同意、研究队伍建设、试验风险管理等方面进行探讨,以期为我国儿童药物临床试验体系完善提供理论参考。Children are a sensitive and special group,and their physical and mental conditions are significantly different from those of adults.There are many factors that need to be considered in the conduct of clinical trials of pediatric drugs.The clinical trial system of pediatric drugs in China is still in its infancy,with some immature aspects that may threaten the safety and rights of the subjects.Based on the characteristics of pediatric clinical trials and the protection needs of children as a special group of subjects,this study explored the aspects such as informed consent,research team building,and trial risk management,in order to provide theoretical references for the improvement of China’s pediatric drug clinical trial system.

关 键 词：药物临床试验 伦理审查 儿童药物 隐私保护 

分 类 号：R969.4[医药卫生—药理学]