浅析我国药物临床试验机构管理中的问题与对策  

Problems and Solutions for the Management of the Drug Clinical Trial Institution in China

作　　者：姚战鹏[1] 贾艳艳[2] 金鑫[1] 王婧雯[2] 杨林[2] 马忠英[2] 文爱东[2] 

机构地区：[1]第四军医大学西京医院科研科,陕西西安710032 [2]第四军医大学西京医院药剂科,陕西西安710032

出　　处：《药学与临床研究》2012年第6期563-565,共3页Pharmaceutical and Clinical Research

基　　金：国家"重大新药创制"十二五科技重大专项(2011ZXJ09202-13)

摘　　要：药物临床试验是对药品在人体进行的安全性和疗效的评价,是药品上市前的最后一道专业屏障。因此,提高新药临床试验质量至关重要,而药物临床试验机构在药物临床试验质量管理中起到十分关键的作用。本文针对目前药物临床试验机构中的问题进行归纳梳理,提出应对策略:药物临床试验机构设置须实体化、工作人员设置须编制化;主要研究者职责与名誉须挂钩,从而确保药物临床试验质量。Drug clinical trial is to evaluate the safety and efficacy of drugs in the human body, which is the last professional barrier before drugs coming into market. Therefore, it is critical to improve the quality of clinical trials of new drugs and reinforce the management of the drug clinical trial institutions in China, which plays a very crucial role in the drug clinical trial quality management. Various problems faced by authorities and institutions were summarized to put forward regulatory measures： it is necessary to make the drug clinical trial institutions to be an entity with authorized staffs, and to integrate the principal investigators’ reputation with their responsibility in clinical trials to ensure the quality of drug clinical trials.

关 键 词：临床试验 机构 管理 问题 

分 类 号：R95[医药卫生—药学]