现实世界的证据时代的分散的临床试验:对最近经验的批判性评估
Hongwei Wang1, Nadia Daizadeh2, Yuan-Li Shen3
1Data and Statistical Sciences, AbbVie, North Chicago, Illinois, USA.
Clinical and translational science
|September 8, 2025
概括
分散临床试验 (DCT) 为患者带来了好处,并提高了概括性,由于大流行,使用量增加. 然而,在DCT中处理间流事件的报告需要更多的关注,以确保可靠的研究结论.
科学领域:
- 临床研究方法论临床研究方法论
- 数字健康创新数字健康创新
- 制药发展 制药发展
背景情况:
- 自2011年以来,分散的临床试验 (DCT) 已经增长,COVID-19大流行加速了这一增长.
- 临床临床治疗提供了以患者为中心的方法,并提高了研究结果的概括性.
- 关键驱动因素包括运营效率,新的研究问题和数字终端验证.
研究的目的:
- 分类和评估23个不同的DCT案例研究的设计和进行.
- 确定DCT实施中的趋势,机遇和挑战.
- 为未来的分散的临床试验设计提供建议.
主要方法:
- 对23个不同治疗领域的案例研究进行了系统审查.
- 评估框架的应用 (ICH E9 (R1)) 用于批判性评估.
- 根据其主要目的对DCT进行分类.
主要成果:
- 通过必要性,运营效益,研究问题,数字终点或平台验证来对DCT进行分类.
- 确定了DCT的共同趋势和机遇.
- 在DCT中处理间流事件的报告策略中发现了一个显著的差距.
结论:
- DCT为临床研究提供了有价值的模型,提供了显著的优势.
- 处理间流事件需要在DCT设计和报告中更加专注.
- 解决这个差距对于加强DCT结果的可靠性和有效性至关重要.
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