临床试验机构建立多层次全方位立体式质量控制模式的探索与实践  

Exploration and practice of establishing multi-level and all-round three-dimensional quality control model in clinical trial institutions

作　　者：陆明莹[1] 刘妤[1] 张田香[1] 张彩霞[1] 易秋月 LU Ming-ying;LIU Yu;ZHANG Tian-xiang;ZHANG Cai-xia;YI Qiu-yue(Office of Drug Clinical Trial Institution,First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061,China)

机构地区：[1]西安交通大学第一附属医院临床药理机构办公室,西安710061

出　　处：《中国新药杂志》2022年第14期1407-1410,共4页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2020ZX09201020)。

摘　　要：药物临床试验是验证新药有效性和安全性的关键环节,其结果和研究数据是药物上市的主要依据,项目质量和数据可靠性决定着老百姓的用药安全。药物临床试验机构如何确保高质量地完成每一个项目成为机构管理的热点和难点,仅依靠简单的质量控制是难以完成的。本文通过分析目前机构质量管理存在的问题,结合多年的临床实践,探讨采用多种方式,调动多种力量,建立多层次、全方位、立体式的机构质量控制模式的可行性,在有限的人力配置下做到项目全流程质量管理,从而保证项目的质量。Drug clinical trial is the key process to evaluate the efficacy and safety of a new drug.Whether a drug can get into the market or not is based on the trial result and data.It is the trial quality and data reliability that determine the safety of drug use among the public.However,it is difficult to complete every clinical trial with high quality only via superficial quality control;hence,how to assure the trial quality has become a hot and difficult topic for the trial management.By analyzing the existing problems discovered by quality control and by combining years of clinical practice with trial management,this article aims to discuss the feasibility of establishing a multi-level,omnidirectional and three-dimentional quality control mode.Also,this article explores how to achieve a comprehensive process management of high-quality for drug clinical trial with limited staffing by taking various methods and mobilizing diverse forces.

关 键 词：临床试验 质量控制模式 临床试验机构 

分 类 号：R95[医药卫生—药学]