项目全生命周期视角下美国创新药临床试验管理实践及启示

Practices of innovative drug clinical trials management in the US and implications from the perspective of project whole life cycle

目的:为完善我国创新药临床试验管理提供参考。方法:从项目全生命周期视角出发,分析创新药临床试验所属的复杂项目体系,探讨美国促进创新药临床试验开展的政策措施及监管经验,并提出对我国相关工作的建议。结果与结论:创新药临床试验项目流程复杂且各主体利益诉求不尽相同,存在一定的监管难点。美国通过适时地颁布各类现代化监管计划及临床试验指导文件,促进了创新药临床试验在方案设计、审评审批、研究启动、伦理审查及数据共享等全生命周期流程的严谨性和高效性,为我国优化创新药临床试验的管理路径提出建议,探索“主方案”试验设计模式为新疗法临床试验提供进一步保障,通过优化的试验启动运作程序、独立审查与专科化伦理审查并行的机制及多样化数据共享模式,确保临床试验高效性,不断完善审评信息公开和利益相关者沟通机制,加强创新药临床试验立项引导。

Objective:To provide reference for improving the management of innovative drug clinical trial in China.Methods:From the perspective of the project whole life cycle,this paper analyzes the complex project system of innovative drug clinical trials,discusses the measures and regulatory experience in promoting the development of innovative drug clinical trials in the United States,hoping the suggestions were useful for China.Results Conclusion:The process of innovative drug clinical trial projects is complex and the interests of different subjects are different,therefore certain regulatory difficulties exist.Through timely promulgation of various modern regulatory program and clinical trial guidance documents,the United States has promoted the rigor and efficiency of innovative drug clinical trials in the whole life cycle process of protocol design,review and approval,study start-up,ethical review,and data sharing.It is suggested that China should optimize the management path of innovative drug clinical trials from the following aspects,and explore the “master protocol” trial design model to provide further guarantee for clinical trials of new therapies:initiating operation procedures based on optimized trial,applying parallel mechanism of independent review and specialized ethical review,and using diversified data sharing models,in order to ensure efficient clinical trials.The review information disclosure and stakeholder communication mechanism should be constantly improved to strengthen the guidance of innovative drug clinical trial project.