卫报研究网络:用于药物流行病学研究和监管应用的真实世界数据源
Andrea McCracken1, Julien Heidt2, Elizabeth Eldridge2
1Guardian Research Network, Spartanburg, South Carolina, USA.
Pharmacoepidemiology and drug safety
|September 8, 2025
概括
确保高质量的真实世界数据 (RWD) 对监管决策至关重要. 这项研究详细介绍了卫报研究网络.
科学领域:
- 现实世界数据 (RWD) 质量评估
- 监管科学是一种监管科学.
- 医疗信息学 医疗信息学
背景情况:
- 现实世界数据 (RWD) 质量对于生成可靠的现实世界证据 (RWE) 对于监管提交至关重要.
- 数据所有者必须为监管机构记录数据质量评估.
- 评估数据的可靠性,包括其旅程,与其对有效结论的相关性同样重要.
研究的目的:
- 为守护者研究网络 (GRN) RWD源复制数据质量属性的透明报告.
- 为了描述GRN的质量属性,汇总电子健康记录 (EHR) 的数据库.
- 为了使GRN的数据质量框架与既定指南保持一致.
主要方法:
- 描述了GRN数据元素,及时性,代表性和访问.
- 确保和评估数据可靠性 (准确性,可追溯性,及时性,完整性) 和相关性 (可用性,充分性,代表性) 的详细方法.
- 提供了数据质量检查的示例,以及 GRN.内数据质量检查的结果.
主要成果:
- GRN采用结构化流程,以确保数据的可靠性和相关性,符合已公布的指南.
- 针对GRN数据进行了具体的数据质量检查,并记录了其结果.
- 这项研究表明了对RWD质量保证的系统方法.
结论:
- 记录和传达RWD质量属性对于监管使用至关重要.
- 透明的报告提高了可行性评估,并建立了监管机构对RWE的信心.
- 结构化方法对于识别监管准备的数据源至关重要.
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