基于区块链的临床试验数据流转模式探索与设计  

Exploration and design of blockchain-based clinical trial data flow model

作　　者：邹淘 梁会营[1] 李丹[2] 刘昭欣 廖天正 林晓兰 梁铭标 杨小红 ZOU Tao;LIANG Huiying;LI Dan;LIU Zhaoxin;LIAO Tianzheng;LIN Xiaolan;LIANG Mingbiao;YANG Xiaohong(Information Management Department,Guangdong Provincial People's Hospital Affiliated to Southern Medical University(Guangdong Academy of Medical Sciences),Guangzhou 510080,Guangdong Province,China;Medical Equipment Department,Guangdong Provincial People's Hospital Affiliated to Southern Medical University(Guangdong Academy of Medical Sciences),Guangzhou 510080,Guangdong Province,China;Hospital Office,Guangdong Provincial People's Hospital Affiliated to Southern Medical University(Guangdong Academy of Medical Sciences),Guangzhou 510080,Guangdong Province,China)

机构地区：[1]南方医科大学附属广东省人民医院(广东省医学科学院)信息管理处,广州510080 [2]南方医科大学附属广东省人民医院(广东省医学科学院)医疗设备处,广州510080 [3]南方医科大学附属广东省人民医院(广东省医学科学院)医院办公室,广州510080

出　　处：《中国数字医学》2024年第1期16-23,共8页China Digital Medicine

基　　金：国家重点研发计划-面向卫生健康数据的区块链平台及示范应用(2022YFB2703304)。

摘　　要：目的:基于区块链技术,使临床试验数据在流转过程中可进行分步溯源,提升数据的可信度和质量。方法:运用区块链共享账本、隐私保密技术对药品在临床试验期中的流通进行登记,使临床试验全生命周期数据溯源成为可能,结合对象标识符(OID)技术对临床试验药品进行赋码,对在临床试验中流通的药品进行数据流通标记。结果:初步完成了基于区块链的临床试验研究系统的建设框架。结论:基于区块链在药物临床试验中的应用可行性研究,可有效解决临床试验数据流转管理过程中的现实痛点,包括数据信任、数据流转可追溯性、数据传输速度和数据处理质量等问题,有效提升临床试验数字化程度。Objective Based on blockchain technology,clinical trial data can be traced step by step in the flow process to improve the credibility and quality of data.Methods Blockchain shared ledger and privacy technology were used to register the circulation of drugs in the clinical trial period,so as to make it possible to trace the data of the whole life cycle of clinical trials.Clinical trial drugs were coded with object identifier(OID)technology,and the data circulation of the drugs in clinical trials was marked.Results The construction framework of blockchain-based clinical trial research system was preliminarily completed.Conclusion The feasibility study of blockchain application in drug clinical trials can effectively solve the realistic pain points in the process of clinical trial data flow management,including data trust,data flow traceability,data transmission speed and data processing quality,and effectively enhance the degree of digitization in clinical trials.

关 键 词：区块链 对象标识符 药物临床试验 

分 类 号：R197.3[医药卫生—卫生事业管理] R319[医药卫生—公共卫生与预防医学]