设计,实施和与依赖电子病历数据的临床试验相关的推断问题:叙述性审查
Alan Leviton1, Tobias Loddenkemper2
1Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. alan.leviton@childrens.harvard.edu.
BMC medical research methodology
|November 17, 2023
概括
在临床试验中,越来越多地使用现实世界的证据,特别是电子健康记录 (EHR) 的证据. 以EHR为来源的试验为评估治疗方法的传统随机临床试验提供了具有成本效益的替代方案.
科学领域:
- 医疗信息学 医疗信息学
- 临床研究 临床研究
- 监管科学 监管科学
背景情况:
- 现实世界证据 (RWE) 现在被监管机构接受用于评估治疗益处和危害.
- 电子健康记录 (EHR) 包含有价值的现实世界的数据.
- 传统的随机临床试验 (RCT) 昂贵且耗时.
研究的目的:
- 审查EHR来源的试验设计.
- 讨论与EHR来源的试验相关的伦理考虑.
- 突出EHR来源的试验在研究和监管决策中的潜力和局限性.
主要方法:
- 选择的文献评论.
- 对EHR来源的试验研究设计的分析.
- 讨论道德方面的影响.
主要成果:
- 基于EHR的试验比传统的RCT要便宜得多.
- 这些试验有可能在EHR系统中增强共同的数据元素.
- 在从EHR数据中推断因果关系时,需要谨慎.
结论:
- 由于其成本效益,预计EHR来源的试验将增加.
- 这些试验可以为回答研究和监管问题做出重大贡献.
- 需要进一步的开发和仔细的应用,以获得强大的因果推理.
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