研究者发起的临床研究项目监管体系:现状与进展  

Regulatory framework of investigator-initiated trials: retrospect and prospect

作　　者：李奕萱 谢丽 钱碧云 LI Yi-xuan;XIE Li;QIAN Bi-yun(Clinical Research Institute,Shanghai Jiao Tong University School of Medicine,SHANGHAI 200025,China)

机构地区：[1]上海交通大学医学院临床研究中心,上海200025

出　　处：《中国新药与临床杂志》2020年第3期146-150,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：研究者发起的临床研究(IIT)在医疗学术、产业中占有越来越重要的地位。不同于以药物注册为目的的临床研究,IIT需要符合其特点的监管模式。本文通过汇总分析国际上IIT监管法规框架,结合我国现有的临床研究监管政策和指导文件,分析我国IIT监管体系现状,提出监管主体和工作流程不明确、质量评估指标缺失、科学性要求不足等IIT科学监管存在的问题以及相关改进建议,为我国IIT监管体系的构建提供参考。Investigator-initiated trials(IIT)show increasing importance in medical academia and industry.Different from the trials for new drug registration,IIT require distinguishable regulation models.Based on the analysis of the regulatory framework of IIT in the world and the existing regulatory policies and guidance documents of clinical research in China,the current situation of IIT regulatory system in China was analyzed in this paper and existing problems such as unclear supervision subject and workflow,lack of quality evaluation index,and lack of scientific requirements were discussed,in order to provide reference for the construction of IIT regulatory system in our country.

关 键 词：研究人员 临床研究 质量控制 组织和管理 

分 类 号：R95[医药卫生—药学]