FDA儿童药物临床试验规范化对我国的启示  

The Enlightenment of FDA’s Standardization of Clinical Trials of Drugs Involving Children to China

作　　者：李威[1] 刘进[2] 张雪[1] 王子颖慧 尹梅[1] LI Wei;LIU Jin;ZHANG Xue(College of Humanities and Social Sciences,Harbin Medical University,Harbin 150081,China)

机构地区：[1]哈尔滨医科大学人文社会科学学院,黑龙江哈尔滨150081 [2]哈尔滨医科大学纪委办公室,黑龙江哈尔滨150081

出　　处：《医学与哲学》2022年第23期22-24,28,共4页Medicine and Philosophy

基　　金：2021年中央支持地方高校改革发展资金项目:药物临床试验伦理审查规范化问题研究;2021年黑龙江省基本科研业务费项目(2021-KYYWF-0304)。

摘　　要：对美国食品药品监督管理局(Food and Drug Administration,FDA)儿童药物临床试验的规范化进行界定,发现我国面临儿童用药方面存在安全隐患、儿童药物临床试验存在需求缺口、儿童药物临床试验审查不够规范等现实困境,引发规范儿童药物临床试验的关键性思考。借鉴FDA对儿童药物临床试验的规范化实践,总结FDA儿童药物临床试验相关法案、临床试验指南文件以及对伦理审查委员会的监管措施,得出完善儿童药物临床试验专门法规和指南、加强相关伦理委员会监管和指导、规范儿童药物临床试验伦理审查、加大儿童受试者保护力度等对我国的启示。This paper defines the standardization of Food and Drug Administration(FDA)’s clinical trials of drugs involving children, and finds that there are some practical dilemmas in China, such as potential safety hazards, demand gap, and inadequate pharmaceutical review, which leads to key thinking on standardizing clinical trials of drugs involving children. By referring to FDA’s standardized practice in clinical trials of children’s drugs, this paper summarizes FDA’s related bills, clinical trial guidance documents and supervision measures for the ethical review committee, and draws some enlightenment to China, such as perfecting the special regulations and guidelines for clinical trials of drugs involving children, strengthening the supervision and guidance of relevant ethical committees, standardizing the ethical review of clinical trials of drugs involving children, and strengthening the protection of children subjects.

关 键 词：美国食品药品监督管理局 儿童药物临床试验 规范化 

分 类 号：R-05[医药卫生]