我院临床试验用药品的管理体会  

Management Experience of Clinical Trial Drugs in Our Hospital

作　　者：孙成春[1] 李朝武[2] 董玉波[1] 吕伟伟[1] 舒鹤[1] 康长清[1] 

机构地区：[1]济南军区总医院药剂科,济南250031 [2]山东大学齐鲁医院药物临床试验机构办公室,济南250012

出　　处：《中国药房》2013年第17期1573-1575,共3页China Pharmacy

基　　金：国家科技部“重大新药创制”创新药物研究开发技术平台建设资助课题(No.2012ZX09303-016-003)

摘　　要：目的:探讨临床试验用药品的管理模式。方法:比较目前临床试验用药品的两种管理模式(专业管理药品与设立中心试验药房管理药品)的优缺点,并介绍我院建立中心试验药房管理试验用药品的做法和体会。结果与结论:两种管理模式各有利弊,但在我院的实践中,认为采用中心试验药房管理模式在对试验用药品的管理上更具有显著的优势,其可集中统一管理试验用药品,通过制定并不断完善相关管理制度,促进药物临床试验的规范开展和保障结果的可靠性。OBJECTIVE. To discuss management model of clinical trial drugs. METHODS： 2 kinds of management models （professional drug management and centre trial pharmacy） for clinical trial drugs were compared in terms of disadvantage and advantage. The methods and experience of trial drugs management by centre trial pharmacy model were introduced by our hospital. RESULTS ＆ CONCLUSIONS： There are own advantages and disadvantages in 2 management models. In the practice of our hospital, it is remarkably superior for model of centre trial pharmacy about management of trial drugs. Centre trial pharmacy model can achieve centralized management of trial drugs, which promotes the development of clinical trials and reliability of trial results.

关 键 词：中心试验药房 临床试验用药品 管理 

分 类 号：R95[医药卫生—药学]