通过代币化将临床试验参与者与他们的美国现实世界数据联系起来:一本实用指南
Michael J Eckrote1, Carrie M Nielson2, Mike Lu2
1HealthVerity, Philadelphia, PA, USA.
Contemporary clinical trials communications
|September 16, 2024
概括
将真实世界数据 (RWD) 与临床试验数据联系起来,可以促进药物开发. 这种方法通过连接碎片化的健康信息,同时保持患者隐私,提高了治疗理解和试验通用性.
科学领域:
- 医疗信息学 医疗信息学
- 临床试验 临床试验
- 现实世界的数据分析.
背景情况:
- 现实世界数据 (RWD) 提供了超越临床试验的患者体验和治疗效果的见解.
- 电子健康记录 (EHR) 数据集成在试验中很常见,但由于数据碎片化而面临挑战.
- 连接不同的RWD来源和试验数据对于全面的证据生成至关重要.
研究的目的:
- 描述将现实世界数据 (RWD) 与临床试验数据联系在一起的应用.
- 突出RWD链接对临床开发和现实世界决策的好处.
- 在临床研究中解决隐私保护RWD链接的操作考虑.
主要方法:
- 使用代币化来保护RWD和临床试验数据的隐私链接.
- 采用保护隐私的记录链接系统,使用准确和精确的指标.
- 实施参与者同意管理和RWD访问的现场培训.
主要成果:
- RWD链接提高了临床试验结果的解释性和概括性.
- 它有助于解决缺失的数据和在试验中丢失的后续行动.
- 延长患者的随访超越试验完成,并表征试验适用于不同人群.
结论:
- 将RWD与临床试验数据联系起来,弥合了证据差距,并提高了试验结果的概括性.
- 保护隐私的链接方法对于道德和有效的数据集成至关重要.
- 操作准备,包括同意和培训,是成功在试验中实施RWD链接的关键.
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