演变为下一代ACT网络:一个不断发展的开放式访问,现实世界的数据资源,为临床和翻译科学奖联盟的现实世界的证据研究做好了准备
Elaine H Morrato1,2, Lindsay A Lennox3, James W Dearing4
1Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Chicago, IL, USA.
Journal of clinical and translational science
|November 29, 2023
概括
从ACT网络中吸取的经验教训为开发ENACT提供了信息,ENACT是访问电子健康记录数据的下一代平台. 这一举措增强了现实世界数据研究能力,用于多个地点的研究和监管决策.
科学领域:
- 翻译科学 翻译科学
- 医疗信息学 医疗信息学
- 实施科学 实施科学
背景情况:
- ACT网络为临床和翻译科学奖 (CTSA) 联盟的研究人员提供了访问联合电子健康记录 (EHR) 数据的便利.
- 该计划已被退还并扩展为"演化为下一代ACT" (ENACT).
- 美国食品和药物管理局正在越来越多地评估现实世界数据 (RWD) 和现实世界证据 (RWE) 以达到监管目的.
研究的目的:
- 介绍从ACT网络的实施中吸取的六个经验教训,以告知ENACT基础设施的发展.
- 通过与CTSA中心和调查人员的客户发现访谈来确定未满足的RWD需求.
- 根据研究阶段,为ENACT提出价值主张假设.
主要方法:
- 应用实施科学原则来分析ACT网络的成功.
- 使用Innovation-Corps@NCATS (I-CorpsTM) 方法进行客户发现访谈.
- 为ENACT平台开发价值主张假设.
主要成果:
- 确定了开发和维持RWD/RWE基础设施的六个关键教训.
- 课程包括机构关系管理,最终用户参与,测试和客户驱动的适应.
- 客户发现面试正在进行中,以揭示特定的RWD需求.
结论:
- 来自ACT网络的见解为ENACT的成功发展和可持续性提供了基础.
- 维持学术衍生数据基础设施对于推进翻译科学至关重要.
- 这项工作支持该国的RWD/RWE研究能力.
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