研究者发起的临床研究用于支持新药研发面临的挑战  

Challenges of Investigator-initiated Clinical Trials to Support the New Drug Development

作　　者：白桦[1] 张抒扬[2] Hua BAI;Shuyang ZHANG(Department of Scientific Research,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China;Department of Cardiology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China)

机构地区：[1]北京协和医院科研处,北京100730 [2]北京协和医院心内科,北京100730

出　　处：《中国肺癌杂志》2022年第7期511-516,共6页Chinese Journal of Lung Cancer

基　　金：北京市研究型病房示范建设单位项目(No.BCRW202001)资助。

摘　　要：在我国开展的大量研究者发起的临床研究(Investigator-initiated clinical trials,IIT),其中部分应该可以为新药研发起到重要的支撑作用。但由于我国IIT尚存在数量多、规模小、质量参差不齐等问题,特别是在方案设计、质量管理以及伦理审查能力等方面与制药企业发起的注册临床试验还存在不小的差距,导致很多IIT还不能用于支持新药研发。因此需要监管部门、申办方、研究机构、伦理委员会和研究者共同提高对于IIT用于支持新药研发作用的认识。只有加强监管,建立有效的质量管理体系、强化对研究者的培训并切实提升伦理审查能力,才能用高质量的研究者发起的临床研究支持新药研发。A large number of investigator-initiated clinical trials(IIT)were conducted in China,some of them should play an important supporting role in new drug development.Due to the large number,small scale and uneven quality of IIT in China,especially a big gap between the IIT and industry-sponsored trials in terms of protocol design,quality management and ethical review,many IIT can’t be used to support the new drug development.Therefore,it is necessary for regulatory authorities,sponsors,research institutions,ethics committees and researchers to improve their understanding of the role of IIT.In order to support the new drug development with high-quality IIT,formulating supervising system,establishing an effective quality management system,enhancing the training of researchers and improving the ability of ethical review should be implemented effectively.

关 键 词：研究者发起的临床研究 新药研发 质量管理 伦理审查 

分 类 号：R95[医药卫生—药学]