临床试验用药品管理问题及改进措施  

Problems and improving measures of drug management in clinical trials

作　　者：陆瑶[1] 詹惠中 曹钰然[1] 唐兴雨 李彩红 吴翠云[2] 张菁[1] 曹国英[1] LU Yao;ZHAN Huizhong;CAO Yuran;TANG Xingyu;LI Caihong;WU Cuiyun;ZHANG Jing;CAO Guoying(Office of Drug Clinical Trials Institution,Huashan Hospital,Fudan University,Shanghai 200040,China;Institutional Review Board,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院药物临床试验机构办公室,上海200040 [2]复旦大学附属华山医院伦理审查委员会,上海200040

出　　处：《中国临床药学杂志》2022年第6期435-438,共4页Chinese Journal of Clinical Pharmacy

基　　金：上海市促进市级医院临床技能与临床创新能力三年行动计划资助项目(编号20CR4002B);上海市科技计划项目—2021年度软科学研究计划定向委托项目(编号21692110202)

摘　　要：目的探讨临床试验用药品管理问题以及改进措施。方法采用回顾性方法,对医院药物临床试验机构近5年来质控中发现的试验用药品管理问题进行分析。结果医院在2016年7月至2021年6月质控过程中共发现问题272个,其中与试验用药品相关的问题有62个(占22.79%),主要为药物储存问题(25个,占40.32%)、接收问题(15个,占24.19%)及回收问题(13个,占20.97%)等。针对临床试验用药品管理问题,提出了相应的解决措施及改进方法。结论药物临床试验机构应在试验用药品管理质控、管理制度、标准操作规程、人员培训、中心药房和信息化系统管理等方面加强并完善,提高试验用药品的管理水平,完善试验用药品的管理模式,保证药物临床试验质量。AIM To explore the problems and improving measures of drug management for clinical trials.METHODS Retrospective method was used to analyze problems of investigational drug management found in the quality control of drug clinical trial institution of our hospital in recent 5 years.RESULTS A total of 272 problems were found in the quality control from July 2016 to June 2021,among which 62 problems(22.79%)were related to investigational drugs,mainly including storage problems(25,40.32%),reception problems(15,24.19%)and recovery problems(13,20.97%),etc.In view of the problems of drug management in clinical trials,corresponding solutions and improving methods were put forward.CONCLUSION Clinical trial institution should strengthen and improve quality control,management system,standard operating procedures,personnel training,central pharmacy,information system management of investigational drugs,and thus to improve the management level of investigational drugs,promote the management mode of investigational drugs,and ensure the quality of drug clinical trials.

关 键 词：临床试验 药品管理 问题 措施 

分 类 号：R95[医药卫生—药学]