研究者视角:优化临床试验审评审批机制的机遇与挑战  

Investigator Perspectives:Opportunities and Challenges in Optimizing the Clinical Trial Application Review and Approval Mechanism

作　　者：严钰茸 曹钰然[2] 曹国英[1,2] 武晓捷[1] 何金杰 张菁[1,2] YAN Yu-rong;CAO Yu-ran;CAO Guo-ying;WU Xiao-jie;HE Jin-jie;ZHANG Jing(Clinical Pharmacology Research Center,Huashan Hospital,Fudan University;Drug Clinical Trial Institute,Huashan Hospital,Fudan University)

机构地区：[1]复旦大学附属华山医院临床药理研究中心 [2]复旦大学附属华山医院药物临床试验机构

出　　处：《中国食品药品监管》2025年第2期44-49,共6页China Food & Drug Administration Magazine

基　　金：科技部“重大新药创制”科技重大专项(2017ZX09304005)。

摘　　要：2024年7月国家药监局启动了优化创新药临床试验审评审批试点工作,显著缩短了1类创新药临床试验申请审评审批时间,提高了创新药物研发的效率。本文基于研究者视角,通过分析国内外创新药临床试验审评审批体系,结合我国当前试点工作的实施情况,旨在探讨该试点工作对临床试验机构、伦理委员会和研究者带来的机遇与挑战,并提出相应的思考和策略。该试点工作要求临床试验机构、伦理委员会及研究者在创新药物研发过程中承担更为关键的责任,亟需进一步强化临床试验机构与伦理委员会有机协作,优化风险管理机制,并增强研究者在早期临床试验中的核心作用。通过多方协作,确保试点工作及临床试验的科学、规范与高效实施,可为我国药品监管的国际化和创新药物研发的高效推进提供有力保障。In July 2024,the National Medical Products Administration(NMPA)launched a pilot program to optimize the clinical trial review and approval process for innovative drugs,significantly shortening the approval timeline for Category 1 drug applications and improving R&D efficiency.This paper,from the investigator perspective,analyzes domestic and international clinical trial review and approval systems,evaluates the implementation of pilot program,and explores its opportunities and challenges for clinical research institutions,ethics committees,and investigators.The pilot program requires these stakeholders to assume greater responsibilities in innovative drug development,necessitating stronger collaboration between institutions and ethics committees,optimize risk management mechanisms,and a more central role for investigators in early-phase clinical trials.A multi-party,coordinated approach will be key to ensuring scientific,standardized,and efficient implementation of the pilot program and clinical trials,ultimately supporting the internationalization of China’s drug regulatory framework and accelerating innovative drug development.

关 键 词：优化审评审批 研究者视角 风险管理 创新药 临床试验基金项目 

分 类 号：R95[医药卫生—药学]