基于可信样本溯源的生物医药研发数据共享框架研究OA
Framework of data sharing of biomedicine R&D on the basis of trusted sample traceability
目的:构建基于可信样本溯源的生物医药研发数据共享框架平台,以应对长三角区域生物医药研发中数据协同共享存在的问题,提升数据要素价值释放效率.方法:基于区块链技术构建可信样本溯源生物医药研发数据共享框架平台,对生物样本全生命周期流转进行可追溯管理,确保其衍生组学等研发数据在共享过程中的真实与合规性;整合样本全流程追溯、数据安全管理与合规应用3大核心系统,利用智能合约实现关键操作的确权与存证,并结合数据沙箱技术实现数据"可用不可见".通过平台核心功能原型系统,以非小细胞肺癌患者的高通量测序(NGS)检测样本可信流转为例,验证平台功能.结果:平台可实现非小细胞肺癌患者的NGS检测样本从医院端发出,到独立医学实验室(ICL)完成检测,最终数据被科研机构合规使用的全过程,表明该平台能够显著提升生物样本与相关数据流转过程的透明度,并有效保障数据共享的规范性与可追溯性,形成从样本流转到数据应用的闭环管理体系.结论:基于可信样本溯源的生物医药研发数据共享框架平台,能够实现对样本全生命周期的透明追溯和对数据全流程的安全可控管理,可作为解决区域生物医药研发数据共享难题的有效路径.
Objective:To construct a framework platform of data sharing of biomedicine research and development(R&D)on the basis of trusted sample traceability,so as to cope with the existed problems in collaborative sharing for data in biomedical R&D in the Yangtze River Delta region,and improve release efficiency of the value of data elements.Methods:The framework platform of data-sharing of biomedicine R&D of trusted sample traceability was constructed on the Blockchain technique.The traceability management about the full lifecycle circulation of biological sample was conducted,so as to ensure the authenticity and compliance of R&D data of derivative omics of that.It integrated three core systems included full-process traceability of sample,security management of data,and compliant application of data,which utilized intelligent contract to realize confirmation and certification of key operation,and combined data sandbox technique to realize"usable but invisible".The trusted circulation of tested samples with next-generation sequencing(NGS)of patients with non-small cell lung cancer was used as samples to verify the function of platform through prototype system of core function of platform.Results:The entire process,in which NGS testing samples of patients with non-small cell lung cancer were sent from hospital to an independent clinical laboratory(ICL)to complete test,and the data were ultimately used by science and research institution as compliance approach,demonstrated that this platform can significantly improve the transparency of the circulation process from biosample to relevant data.It can effectively ensure the compliance and traceability of data sharing,and form a closed-loop management system from sample circulation to data application.Conclusion:The framework platform of data sharing of biomedicine R&D based on trusted sample traceability can realize management for transparent traceability of full lifecycle of sample,and for safe controllability of data in full lifecycle,which can be used as effective approach of effective resolving difficult problem of data sharing of regional biomedicine R&D.
曹青;廖芬;张佳颖;林靖生
上海交通大学医学院附属瑞金医院学科规划与大设施管理处 上海 200025广慈-思南技术转化服务中心 上海 200025广慈-思南技术转化服务中心 上海 200025上海交通大学医学院附属瑞金医院学科规划与大设施管理处 上海 200025
医药卫生
区块链可信样本溯源数据共享生物医药
BlockchainTrusted sample traceabilityData sharingBiomedicine
《中国医学装备》 2026 (6)
89-95,7
上海市2023年度"科技创新行动计划"长三角科技创新共同体领域项目(23002440100)Shanghai 2023"Science and Technology Innovation Action Plan"Project in the Yangtze River Delta Science and Technology Innovation Community Field(23002440100)
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