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TransFAIR研究:一个欧洲多中心实验,将EHR2EDC技术与用于eCRF数据收集的通常手动方法进行比较

Nadir Ammour¹, Nicolas Griffon^2,3, Juliette Djadi-Prat⁴

¹Clinical Innovation Office, Sanofi SA Recherche & Developpement, Paris, France nadir.ammour@sanofi.com.

BMJ health & care informatics

|June 14, 2023

概括

电子健康记录到电子数据捕获 (EHR2EDC) 模块在现实环境中成功转移了16.9%的临床试验数据. 这符合用于研究日常收集的健康数据的监管目标.

科学领域:

临床信息学临床信息学
健康数据管理管理健康数据
监管科学监管科学

背景情况:

像FDA和EMA这样的监管机构鼓励使用例行收集的数据进行临床试验.
电子健康记录 (EHR) 为研究提供了丰富的现实数据来源.
有效地将EHR数据传输到电子数据捕获 (EDC) 系统对于试验效率至关重要.

研究的目的:

评估EHR到EDC (EHR2EDC) 模块在现实生活条件下将患者数据从EHR传输到EDC系统的准确性.
在临床研究中评估EHR2EDC技术在各种治疗领域的性能.

主要方法:

一项前性研究涉及三个欧洲医院的六项临床试验.
手动收集的数据与通过EHR2EDC模块传输的数据进行比较.
结果以准确传输数据的百分比来衡量,分析人口统计,生命体征,实验室和并发药物.

主要成果:

EHR2EDC模块准确地传输了研究范围内的16.9%的所有数据点和39.6%的数据.
实验室 (LB) 数据显示传输精度最高 (65.4%),其次是生命体征 (VS) (30.8%).
人口统计 (DM) 和并发药物 (CM) 的转移率较低 (分别为0.7%和3.1%).

结论:

该研究实现了使用EHR2EDC模块准确地传输至少15%手动输入的试验数据的目标.
成功的结果归功于医院,工业和技术提供商之间的合作.
未来的努力应优先考虑数据标准的协调和互操作性,以增强EHR数据传输能力.

关键词:

数据管理数据管理电子健康记录电子健康记录健康信息的互操作性互操作性医疗信息学医疗信息学

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