临床研究数据管理与共享最新进展

Advances in Clinical Research Data Management and Sharing

精准医学的发展需要规范的数据管理体系和高效的数据共享来推动。我国的临床数据管理标准在国际现行规范的基础上加强了集中管控和资质监管。21世纪初期,欧美国家通过建立集成型的卒中数据库来促进数据共享,我国也在2018年提出科学数据开放汇交的指导原则。国家神经系统疾病临床医学研究中心通过制定临床研究公共数据标准、整合专病数据资源目录,搭建了符合FAIR原则——可查找(findable)、可访问(accessible)、可互操作(interoperable)和可重用(reusable)的脑血管病大数据管理和共享平台,以提高临床研究数据质量和促进科学数据的共享。

The development of precision medicine requires a standardized data management system and efficient data sharing scheme.Based on current international norms,China's clinical data management standards emphasized centralized supervision on research qualification.In the early 21st century,western countries established integrated stroke databases to promote data sharing,and China in 2008 announced principles to encourage data sharing.China National Clinical Research Center of Neurological Diseases,by establishing clinical research public data standards and integrating specialized disease data resource catalogs,built a cerebrovascular disease big data management and sharing platform which conformed to FAIR principle--findable,accessible,interoperable and reusable,to improve clinical research data quality and promote scientific data sharing.