去中心化药物临床试验伦理审查的实践探索  

Practical exploration of ethical review in decentralized drug clinical trials

作　　者：左旭 黄樱硕[1] 李悦[1] 邢荔函 杨春秀[2] 崔焱[2] ZUO Xu;HUANG Yingshuo;LI Yue;XING Lihan;YANG Chunxiu;CUI Yan(Department of Science and Technology,Beijing Friendship Hospital Affiliated to Capital Medical University,Beijing 100050,China;Office of the Drug Clinical Trial Institutions,Beijing Friendship Hospital Affiliated to Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院科技处,北京100050 [2]首都医科大学附属北京友谊医院药物临床试验机构办公室,北京100050

出　　处：《中国医学伦理学》2025年第1期40-45,共6页Chinese Medical Ethics

基　　金：北京友谊医院科研启动基金“药物临床试验利益相关者2E使用意愿及影响因素研究”(yyqdktgl2021-5)。

摘　　要：目的 探索去中心化药物临床试验伦理审查的流程与指南,推动临床试验进展,保证药物研发进程。方法 通过学习去中心化药物临床试验相关法律法规,分析去中心化药物临床试验的优势与挑战,结合所在机构伦理委员会审查去中心化药物临床试验的经验,总结伦理审查的要点。结果 相关法律法规是伦理审查遵循的基础,伦理委员会应根据法规和医院伦理标准操作规程采用适宜的审查方式,关注点应为去中心化药物临床试验开展的可行性、适用性、合理性,知情同意的充分性,受试者权益及隐私保护以及电子平台资质与标准操作规程。结论 去中心化药物临床试验处于起步阶段,亟须相关法律法规指南的指导,伦理审查也在摸索中不断规范,需监督各方责任落实情况,关注受试者权益,逐步推进去中心化药物临床试验开展。Objective:To explore the process and guidelines for ethical review in decentralized drug clinical trials,promote clinical trial progress,and ensure drug development progress.Methods:The key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials,analyzing the advantages and challenges of decentralized drug clinical trials,and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials.Results:Relevant laws and regulations were the basis for the ethical review,and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures.The ethics committee should focus on the feasibility,applicability,and rationality,the adequacy of informed consent,the protection of rights and interests and privacy of subjects,as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials.Conclusion:Decentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations.Ethical review is also constantly being refined through exploration.It is necessary to supervise the implementation of responsibilities by all parties,pay attention to the rights and interests of subjects,and gradually promote the implementation of decentralized drug clinical trials.

关 键 词：去中心化 药物临床试验 伦理审查 受试者权益 

分 类 号：R-052[医药卫生]