我国开展去中心化临床试验面临的主要风险和挑战及应对思考  

Main Risks,Challenges,and Coping Strategies for Conducting Decentralized Clinical Trials in China

作　　者：张晓方[1,2] 佟天琦 徐岩 孙婉 武阳丰 ZHANG Xiao-fang;TONG Tian-qi;XU Yan;SUN Wan;WU Yang-feng(Clinical Research Institute,Institute of Advanced Clinical Medicine,Peking University;Peking University Health Science-China National Biotech Group Clinical and Regulatory Sciences Joint Laboratory;Drug Clinical Trial Center of Peking University Third Hospital)

机构地区：[1]北京大学临床医学高等研究院,临床研究所 [2]北大医学-中国生物临床与监管科学联合实验室 [3]北京大学第三医院药物临床试验机构

出　　处：《中国食品药品监管》2025年第3期70-81,共12页China Food & Drug Administration Magazine

摘　　要：目的:梳理在我国实施去中心化临床试验(DCT)的主要风险和挑战,以期为DCT在我国的健康发展提供参考。方法:采用方便抽样法选取DCT各相关方代表进行定性访谈,采用主题框架法对访谈资料进行整理分析。结果:DCT各模块的使用程度及各相关方对DCT的认知与实践均有较大差别。目前,DCT各模块实施面临的主要风险和挑战包括:现有医疗体系的架构和基础设施不能满足DCT实施的需要;更为明确的监管措施和政策有待出台予以支持和指引,相关方对未知风险存在担忧,且不同监管部门之间的政策协调有待加强;相关方能力建设有待加强,患者对临床试验的认知和参与不足。结论:建议DCT的开展以患者为中心,并契合临床试验目的;先行先试,产生示范效应,培育DCT在我国发展的土壤;选择有一定实施基础和经验的DCT模块作为突破点,针对其出台行业标准或指导原则,推动其发展和实践,实现以点带面、加速发展DCT的目的;加大培训和沟通支持力度。Objectives:This study aims to identify the main risks and challenges associated with the implementation of decentralized clinical trial(DCT)in China and provide recommendations for the healthy development of DCT.Methods:Representatives from various stakeholders in DCT were selected using a convenient sampling method,and qualitative interviews were conducted to collect data.The thematic framework method was employed to analyze the interview data.Results:There are significant differences in the usage frequency of DCT elements and in the understanding and practice of DCT among stakeholders.The main risks and challenges included:The current healthcare system’s architecture and infrastructure do not meet the needs for DCT implementation;Clearer regulatory initiatives and policies are needed to provide support and guidance,as stakeholders remain concerned about unknown risks,and coordination among different regulatory authorities needs to be strengthened;Capacity building for stakeholders must be enhanced,and patients exhibit insufficient awareness and participation in clinical trials.Conclusion:It is recommended that the implementation of DCT be patient-focused and fit for purpose.A pilot approach should be adopted to generate a demonstration effect and cultivate a supportive environment for DCT in China.DCT elements with a solid implementation foundation and experience should be selected as breakthrough points,and industry standards or regulatory guidance should be issued for these elements to promote their development and practice,ultimately accelerating the broader implementation of DCT.Additionally,increased support for training and communication is essential.

关 键 词：去中心化临床试验 以患者为中心 定性访谈 

分 类 号：R95[医药卫生—药学]