基于现实世界电子健康记录数据的营销后药物评估框架
1Research Center for Healthcare Data Science, Zhejiang Laboratory, Hangzhou, China.
Studies in health technology and informatics
|January 25, 2024
概括
这项研究引入了一个新的框架,使用电子健康记录 (EHR) 数据来评估营销后的药物安全性和有效性. 开发的系统展示了现实世界药物评估的标准化方法.
科学领域:
- 药物监督 药物监督 药物监督
- 医疗信息学 医疗信息学
- 数据科学数据科学数据科学
背景情况:
- 目前,市场营销后药物安全性和疗效的评估缺乏用于利用真实世界数据 (RWD) 的标准化方法.
- 电子健康记录 (EHR) 为临床研究提供了丰富的RWD来源,但需要定制的数据模型和管道来进行有效的药物评估.
研究的目的:
- 通过使用EHR数据,为现实世界药物评估提供一个全面的框架.
- 开发一个标准化的数据模型和统一的管道,用于营销后药物评估.
- 通过一个原型系统和一个案例研究来证明框架的适用性.
主要方法:
- 开发一种定制的数据模型,用于药物上市后的评估.
- 创建一个统一的管道来处理用于药物评估的电子健康记录数据.
- 基于开发的框架实现一个原型系统.
- 应用原型系统来分析来自中国三级医院的现实世界EHR数据 (2010-2020年).
主要成果:
- 基于拟议的框架,成功开发了一种功能原型系统.
- 现实世界EHR数据使用开发的数据模型和管道有效地转换和处理.
- 该系统被用于调查对利和利素过敏反应的风险,展示其实际应用.
结论:
- 拟议的框架提供了一种灵活和统一的方法,用于使用EHR数据进行现实世界药物评估.
- 开发的原型系统证明了该框架在市场营销后药物监测中的可行性和潜力.
- 这种方法可以支持药物评估中的各种研究设计和目的.
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