美国FDA对新药临床试验申办者和合同研究组织的监管模式  

Methods for oversight of sponsors and contracted research organizations in drug clinical trials from United State Food and Drug Administration

作　　者：高敏洁[1] 

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海200020

出　　处：《中国新药与临床杂志》2016年第2期109-113,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：申办者或受其委托的合同研究组织(CRO)是药物临床试验的发起者和管理者,是保证药物临床试验质量的关键责任方。对其实施有效监管应当是药物临床试验监管的重要环节。而我国目前对药物临床试验申办者和CRO的监管措施及监督检查机制尚未健全。本文介绍了美国食品和药物管理局(FDA)对新药临床试验申办者和CRO的监管模式,并总结其中有益的监管经验,以供借鉴。Sponsors or the contracted research organizations（ CROs） take responsibilities for initiation and management of drug clinical trials. Since they are the pivotal part for ensuring the quality of clinical trials,it is important to conduct the effective oversight of them, while there is no sound method for oversight and inspection of them in China up to now. Hence the methods for oversight of sponsors and CROs in drug clinical trials from United States Food and Drug Administration are introduced in this paper for learning their experience.

关 键 词：美国食品和药物管理局 临床试验 申办者 合同研究组织 监管 

分 类 号：R95[医药卫生—药学]