国内外拓展性临床试验制度发展现状及思考  

Developmental status and considerations of global clinical trial systems

作　　者：常凤媛 林琳[1] 田丽娟[1] CHANG Feng-yuan;LIN Lin;TIAN Li-juan(College of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016

出　　处：《中国新药杂志》2024年第8期798-804,共7页Chinese Journal of New Drugs

基　　金：2020年辽宁省教育厅科学研究经费资助项目“构建药品质量监管创新方式的研究”(2020WJC02)。

摘　　要：从不同视角对国内外拓展性临床试验制度加以对比,总结并借鉴国外的成功经验,为我国拓展性临床试验制度进一步完善提供建议与参考。通过文献研究、对比研究、历史研究等方法对国内外拓展性临床试验制度进行研究,发现欧美等国家/地区拓展性临床试验制度体系已较为完善,在适用范围、申请流程和费用支付等方面均作出明确规定,且规范了拓展性临床试验药品的使用和管理,使危重症患者能够得到及时治疗。但我国目前尚处于初步阶段,在落地实施过程中也存在较多问题,如拓展性临床试验制度不完善、申请发起人及费用支付单一化、试验过程中存在的伦理问题等,均影响了制度的实施。建议我国应在完善拓展性临床试验制度相关法规的基础上,通过多方协作实行严格的过程监管,化解申请发起难题,提高审查效率,降低试验操作过程的风险,从而促使我国拓展性临床试验制度进一步健全和完善。By comparing China's and foreign expanded clinical trial systems from different perspectives,summarizing the successful experience of foreign countries,suggestions are provided for the further improvement of the expanded clinical trial system in China.Through the methods of literature research,comparative research,historical research and other methods,the domestic and foreign extended clinical trial system were studies and found that the extended clinical trial system systems of Europe,the United States and other countries/regions have been relatively complete,and the scope of application,application process and payment of fees are clearly stipulated.The use and management of extended clinical experimental drugs were standardized,making critically ill patients get timely treatment.However,China is still in an initial stage,and there are many problems in the implementation process.For example,the implementation of the expanded clinical trial system is affected by the imperfection of the system,the simplification of the application sponsor and the fee payment,as well as the ethical problems in the trial process.It is suggested that on the basis of improving the relevant laws and regulations of the extended clinical trial system in China,strict process supervision should be implemented through multi-party cooperation to resolve the difficulties of application initiation,improve the efficiency of review,and reduce the risks of trial operation,so as to further improve and perfect the extended clinical trial system in China.

关 键 词：拓展性临床试验制度 制度发展 思考及建议 同情用药 

分 类 号：R95[医药卫生—药学]