在临床研究中实施代币化,以扩大现实世界的洞察力
Chelsea Walters1, Crystal S Langlais1,2, Eva E Oakkar1
1Real World Solutions, IQVIA, Durham, NC, United States.
Frontiers in drug safety and regulation
|September 22, 2025
概括
在丰富的临床研究中,令牌化对于将真实世界数据 (RWD) 与初级数据联系起来至关重要. 这篇文章探讨了在美国实施代币化以产生强有力的现实世界的证据.
科学领域:
- 临床研究 临床研究
- 数据科学数据科学数据科学
- 医疗信息学 医疗信息学
背景情况:
- 越来越多的人对使用真实世界数据 (RWD) 进行临床研究越来越感兴趣,特别是对于治疗的安全性和有效性.
- 结合初级和二级RWD的丰富研究越来越普遍,需要先进的数据链接方法.
研究的目的:
- 探索在美国实施代币化的关键方面,以将RWD与初级数据联系起来.
- 定义相关术语,并讨论适当的研究设计和RWD源用于代币化.
- 突出利益相关者在使用代币化生成真实世界的证据时的优势和考虑.
主要方法:
- 探索代币化作为将二级RWD与初级研究数据联系起来的工具.
- 讨论在研究设置中实施代币化的操作考虑.
- 审查研究设计和适合令牌化的RWD源.
主要成果:
- 代币化是将不同数据源连接到丰富研究中的关键推动因素.
- 确定了在美国实现代币化的关键方面,并解决了被忽视的考虑因素.
- 强调了研究利益相关者的优势和考虑因素,以加强现实世界的证据生成.
结论:
- 代币化是成功进行需要数据链接的丰富研究的重要方法.
- 正确实施和理解代币化对于最大限度地提高RWD在临床研究中的价值至关重要.
- 案例研究说明了令牌化适合实现研究目标的场景.
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