新形势下我国去中心化临床试验的实践建议  

Practice suggestions for decentralized clinical trials in China under the new situation

作　　者：江柯萱 林清暑 周吉银 JIANG Kexuan;LIN Qingshu;ZHOU Jiyin(th Army Hospital of the People’s Liberation Army,Weifang 261042,China)

机构地区：[1]中国人民解放军陆军第八十集团军医院,山东潍坊261042 [2]陆军军医大学第二附属医院,重庆400037

出　　处：《现代医院》2025年第4期524-528,共5页Modern Hospitals

基　　金：陆军军医大学人文社会科学基金重点项目(2022XRW02)。

摘　　要：去中心化临床试验(decentralized clinical trials,DCT)必须坚持“以患者为中心”的核心理念。DCT具有诸多优点,例如更快招募多样性研究参与者,降低参加成本,增加依从性,对研究参与者友好,电子知情同意,快递试验性医疗产品,收集数据便利。我国DCT面临包括临床试验机构和医疗服务的新要求,信息化系统支持不足,电子知情同意的合规性,数据安全与个人信息保护的更高要求,需多方培训等挑战。为加快落实我国DCT,笔者认为可尝试采取以下措施,例如加强信息化基础设施建设有利于基层医疗机构参加和研究参与者数据采用;制定各方沟通渠道和强化培训;谨慎设计方案,制定试验标准操作规程,加强伦理审查;远程安全检测和安全性信息报告;明确数据报告程序,通过数据收集和管理,获得高质量试验数据。Decentralized clinical trials(DCT)must adhere to the core concept of“patient-centered”.DCT has many advantages,such as faster recruitment of diverse study participants,lower participation costs,increased compliance,friendliness to study participants,electronic informed consent,expedited investigational medical product delivery,and convenient data collection.DCT in China faces new requirements for both clinical trial institutions and medical services,inadequate support for information systems,compliance with electronic informed consent,higher requirements for data security and personal information protection,and the need for multiple training,and other challenges.To accelerate the implementation of DCT in China,the author believes that the following measures can be taken,such as strengthening the construction of information infrastructure to facilitate the participation of grassroots medical institutions and data collection of study participants;establishing communication channels and strengthening training;carefully designing the protocol,establishing standard operating procedures for clinical trials,and strengthening ethical review;conducting remote safety monitoring and reporting safety information;clarifying the data reporting procedure and obtaining high-quality trial data through data collection and management.

关 键 词：去中心化临床试验 新形势 中国 建议 

分 类 号：R95[医药卫生—药学] R197