中美儿科临床试验管理的比较研究  

Comparative study on the management of pediatric clinical trials between China and America

作　　者：钟一鸣 张天义 郭文[1] ZHONG Yi-ming;ZHANG Tian-yi;GUO Wen(China National Pharmaceutical Industry Information Center,China State Institute of Pharmaceutical Industry,Shanghai 200040,China)

机构地区：[1]中国医药工业研究总院中国医药工业信息中心,上海200040

出　　处：《中国新药杂志》2021年第14期1302-1308,共7页Chinese Journal of New Drugs

摘　　要：儿科临床试验是指在0~18岁人群中进行药物的系统性研究,儿童作为临床试验的受试者,其试验过程的管理尤为重要,能否高质量地开展儿科临床试验直接影响到儿童用药的上市速度,进而影响到儿童用药的可及性。目前,我国儿科临床试验中尚存在受试者招募困难、试验过程缺乏高质量的规范管理以及在伦理审查把关上还不够严谨等问题。基于此,本文在综合分析美国促进儿科临床试验开展的政策措施及监管经验的基础上,对比我国儿科临床试验相关政策与监管体系,分析我国在儿科临床试验管理上存在的问题,以此提出改善我国儿科临床试验管理的对策建议。A pediatric clinical trial is a systematic study of a drug in people aged 0~18 years. Due to the specialness of the subjects, the process management of pediatric clinical trial is particularly important. Whether a high-quality pediatric clinical trial can be carried out directly affects the marketing speed of pediatric drugs, and then affects the accessibility of pediatric drugs. At present, there are still some problems in pediatric clinical trials in China, such as difficulty in recruiting subjects, lack of high-quality standard management in the trial process, and lack of rigor in the ethical review. Based on a comprehensive analysis of the policies, measures and regulatory experience in promoting the development of pediatric clinical trials in the United States, this paper compared the relevant policies and regulatory systems of pediatric clinical trials in China with those in the United States, and analyzed the problems existing in the management of pediatric clinical trials in China, so as to propose countermeasures and suggestions for improving our management of pediatric clinical trials.

关 键 词：儿童用药 临床试验 政策法规 监管 

分 类 号：R969.4[医药卫生—药理学] R95[医药卫生—药学]