研究单位在药物上市后临床试验中的管理策略  

Strategy for Research Site Management in Clinical Trials of Post-marketing Drugs

作　　者：曹红波[1] 商洪才[2] 

机构地区：[1]天津中医药大学中医药研究院,天津300193 [2]天津中医药临床评价研究所,天津300193

出　　处：《中药新药与临床药理》2013年第5期522-525,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家青年科学基金项目(81202849);国家"重大新药创制"科技重大专项(2008ZX09312-001);教育部新世纪优秀人才计划(NCET-09-0900);天津市高等学校科技发展基金计划(20110202)

摘　　要：研究单位(SITE)的过程管理是药品上市后临床试验质量控制的重要内容。药物上市后临床再评价研究往往规模庞大,涉及数十甚至数百个SITE参加,因此,SITE的管理非常重要。采用适宜的管理策略有助于提高试验质量和研究效率。在药物上市后临床试验中涉及SITE管理的环节诸多,包括SITE的会议(启动会、中期总结会、总结报告会)、过程管理(参研人员的培训、临床监查、数据核查、信息交流)、SITE的调整(SITE的筛选与剔除、参研人员的管理、SITE任务量的调整)、SITE的风险管理(医疗纠纷、受试者变为受害者、募集数量不达标、药品管理混乱、参研人员价值取向)4个方面,本文对此展开探讨,并总结出相应的管理策略。Unified process management in different research sites is important for quality control in clinical trials of post-marketing drugs. Up till now, methods for research sites management are not practical or systematic. The problem of management becomes more prominent in large scale clinical assessment studies that typically involves dozens or even hundreds of research sites. The adoption of appropriate management strategies can help improve study quality and efficiency. Research site management in clinical trials of post-marketing drugs involves sites conference（initial meeting, intermediate-stage summary, seminar）, process management（training for the research staff, clinical inspection, data check, information exchange）, sites adjustment （sites inclusion and rejection, research staff management, sites mission adjustment）, and sites risk management（medical disputes, subjects turning into victim, inadequate recruitment samples, derangement of drug management, value orientation of the research staff）. In this paper, we discussed strategies of sites management in terms of the above four respects.

关 键 词：临床试验 研究单位 管理策略 

分 类 号：R285.6[医药卫生—中药学]