利用现实世界的数据来检测安全信号和风险管理在市场前和市场后的设置
Kathleen M Gavin1, Matthew L Sundermann2, Alethea Wieland2
1Datavant, Phoenix, AZ, United States.
Frontiers in drug safety and regulation
|November 3, 2025
概括
现实世界数据 (RWD) 集成,特别是使用隐私保护记录链接 (PPRL),增强了药物安全监督. 这种方法为积极的药物监测和改进的安全信号检测提供了全面的患者层面的见解.
科学领域:
- 药监和药物安全 药监和药物安全
- 医疗信息学 医疗信息学
- 监管科学 监管科学
背景情况:
- 监管机构越来越重视药物安全的真实世界数据 (RWD).
- 传统的药监方法面临着诸如报告不足和数据碎片化等局限性.
- 像FDA的现实世界证据 (RWE) 计划这样的框架促进了RWD的使用.
研究的目的:
- 检查RWD的整合,特别是通过保护隐私的记录链接 (PPRL),以改善药物监督.
- 要突出链接的RWD如何增强纵向安全监测,同时保护患者的隐私.
- 概述在安全监督中使用链接RWD的监管考虑和最佳实践.
主要方法:
- 审查监管框架及其对RWD利用的影响.
- 分析保护隐私的记录链接 (PPRL) 方法,如代币化,用于消除RWD的识别和链接.
- 检查来自链接RWD的患者级安全数据.
主要成果:
- 链接RWD提供了比传统方法更全面的患者层面的洞察力,捕捉罕见事件和长期风险.
- PPRL 方法可以进行纵向安全监测,并积极检测安全信号.
- 监管合规,包括HIPAA和IRB参与,对于使用非识别的,链接的RWD至关重要.
结论:
- 利用与RWD相关的隐私优先方法,可以实现更主动,更可扩展和更有效的药物监督.
- 这种整合支持更早地发现安全问题,并加强市场后监测.
- 链接的RWD促进了临床试验和现实世界的设置之间的数据连续性,使其成为现代安全监测的基石.
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