在DREAM TO TREAT中使用DataSHIELD进行联合分析
Niels Steen Krogh1, David Prieto-Merino2, Bolaji Coker3
1ZiteLab ApS, Copenhagen, Denmark.
The Journal of investigative dermatology
|September 5, 2025
概括
国际合作是研究新型亚托皮性皮肤炎 (AD) 治疗的关键. 通过使用DataSHIELD的联合网络,可以对五个欧洲注册表中的真实数据进行安全,保护隐私的分析.
科学领域:
- 皮肤病学
- 医疗信息学
- 数据科学
背景情况:
- 新的生物和小分子治疗阿托皮性皮肤炎 (AD) 需要强有力的现实世界证据.
- 获得足够的患者数据样本大小需要国际合作.
- 由于隐私和监管限制,现有的国家注册表面临数据聚合的挑战.
研究的目的:
- 评估国际注册协作的可行性,以收集有关新的全身性阿尔茨海默病治疗的真实数据.
- 建立一个联合网络,在多个国家注册表中进行隐私保护数据分析.
- 在国际数据共享中确保遵守通用数据保护条例 (GDPR).
主要方法:
- 部署一个国际DataSHIELD设置,用于统一分析统一数据.
- 创建一个安全的,维护隐私的分析环境,覆盖五个欧洲的AD注册表.
- 通过与外部分析对联合分析结果的验证.
主要成果:
- 成功建立了由五个国家组成的亚托皮炎登记处网络.
- 展示DataSHIELD在不同注册表中同时进行安全数据分析的能力.
- 验证证实了联合分析结果的可靠性.
结论:
- 基于DataSHIELD的联合分析是一种可行且有价值的皮肤学研究方法.
- 国际TREAT注册工作组成功创建了一个AD数据协作网络.
- 这种模式可用于未来的国际合作, 结合IT和医疗资源.
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