Ⅳ期临床试验规范化管理研究  

Research on standardized management of the phase Ⅳ clinical trial

作　　者：王继年[1] 吴三兵[1] 潘荣华[2] 

机构地区：[1]安徽医科大学第一附属医院教育处,安徽合肥230022 [2]安徽医科大学马克思主义学院,安徽合肥230022

出　　处：《南京医科大学学报（社会科学版）》2016年第3期184-187,共4页Journal of Nanjing Medical University（Social Sciences）

基　　金：国家社会科学基金项目"我国人类遗传资源安全监管法律制度研究"(13BFX128)

摘　　要：Ⅳ期临床试验在我国起步较晚,发展迅速,其研究意义和重要性也逐渐得到认可,但迅速发展的背后存在诸多应该防范的问题。明确Ⅳ期临床试验免费赠药问题、规范机构选择、扩大开展项目范围以及充分发挥机构及伦理委员会职能、强化Ⅳ期临床试验管理等方式,均可有效规范管理。The phase IV clinical trial in China is making a rapid progress despite its late start and its research significance and importance have been recognized gradually. There exist many problems behind the rapid development, while these could be effectively managed and solved by the further definitude of free medicine in the phase IV clinical trial, selection of regulatory institutions, expansion of project scope,development of institutions and ethics committee functions and reinforcement of the IV clinical trial management.

关 键 词：Ⅳ期临床试验 规范性 管理 

分 类 号：R197[医药卫生—卫生事业管理]