药物临床试验质量控制的若干思考及实践  

Thinking and practice about quality control of clinical drug trials

作　　者：元唯安[1] 李珍[1] 蒋健[1] 

机构地区：[1]上海中医药大学附属曙光医院临床药理科,上海201203

出　　处：《药学服务与研究》2014年第4期298-300,共3页Pharmaceutical Care and Research

基　　金：国家科技重大专项重大新药创制资助项目(2012ZX09303009-001);上海市中医药事业发展三年行动计划重大研究项目(ZYSNXD-CC-YJXYY)

摘　　要：目的:探讨当前药物临床试验质量管理中存在的问题及应对策略。方法:分析在药物临床试验质量保证中存在的问题,并结合实际情况提出解决办法。结果:上海中医药大学附属曙光医院结合实际情况采取各种举措,使临床试验质量得到提高。结论:药物临床试验质量的提高需要申办者、研究者及药物临床试验机构各方共同努力。Objective： To explore the problems that existed in clinical drug trials and their countermeasures. Methods： The problems that existed in the quality control of clinical drug trials were analyzed and solutions to those problems were put forth according to practical conditions. Results： In accordance with the practical conditions,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine took various measures to improve the quality of clinical drug trials. Conclusion： The improvement of the quality of clinical drug trials demands combined efforts by sponsors, researchers and drug clinical trial institutions.

关 键 词：药物 临床试验 质量控制 

分 类 号：R969.4[医药卫生—药理学] R197.323.2[医药卫生—药学]