加快eSource在瘤临床试验中的扩展:i~HD工作组倡议
Christophe Maes1, Dipak Kalra2, Tracy Acito3
1Faculty of Medicine and Health Sciences, Department of Public, Ghent University, Ghent, Belgium.
Cambridge prisms. Precision medicine
|November 27, 2025
概括
电子资源扩展工作组正在制定一项路线图,以克服电子健康记录 (EHR) 到电子数据捕获 (EDC) 数据传输用于临床研究的障碍,旨在提高瘤学试验的效率和数据质量.
科学领域:
- 临床研究信息学
- 健康数据管理 管理健康数据
- 瘤学 临床试验 临床试验
背景情况:
- 电子源,特别是电子健康记录 (EHR) 到电子数据捕获 (EDC) 数据传输,为临床研究提供了潜在的好处,包括减少站点负担,提高数据质量和加快试验时间表.
- 尽管有优势,但eSource的广泛采用受到技术,监管和运营方面的挑战的阻碍.
研究的目的:
- 通过健康数据 (i~HD) 的eSource扩展工作组概述欧洲创新研究所的目标,协作方法和主要成果.
- 解决限制eSource在临床研究中的实施障碍.
主要方法:
- 形成一个多利益相关者倡议,涉及领先的瘤中心和制药赞助商.
- 基础资源的开发:准备标准,绩效指标框架和操作操作手册.
- 专注于互操作性,监管调整和现实世界的验证.
主要成果:
- 建立一个以共识为导向的 eSource 采用的路线图.
- 创建实用工具,以指导eSource的实施.
- 证明工作组的框架适用于瘤学以外的其他数据密集型治疗领域.
结论:
- 电子资源扩展工作组提供了一个结构化的方法,以促进在临床研究中采用EHR-to-EDC数据传输.
- 开发的框架和资源旨在克服现有的障碍,促进效率和数据完整性.
- 该倡议的成果旨在广泛适用于各种治疗领域,支持临床试验数据管理的发展.
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