合作计划评估现实世界的数据,用于临床研究和监管决策
Meredith N Zozus1, Byeong Yeob Choi1, Maryam Y Garza2
1University of Texas Health Science Center San Antonio, San Antonio, TX.
概括
该ACE-RWD计划评估现实数据 (RWD) 的质量,将电子健康记录和索赔数据与临床试验进行比较. 这项研究为药物开发的各种数据源的监管使用提供了信息.
科学领域:
- 医疗信息学 医疗信息学
- 监管科学 监管科学
- 临床研究 临床研究
背景情况:
- "21世纪治疗法"使FDA能够使用现实世界数据 (RWD) 进行监管决策.
- 关于不同类型的RWD类型的比较质量存在有限的指导.
- 评估RWD质量对于其有效融入药物开发和市场后监测至关重要.
研究的目的:
- 将各种真实世界数据 (RWD) 源与传统临床试验数据的质量进行比较.
- 评估电子健康记录 (EHR) 临床数据,EHR计费数据和相关的医疗保健索赔数据.
- 为监管使用提供有关不同RWD类型相对质量的指导.
主要方法:
- 该ACE-RWD计划进行RWD来源的比较质量评估.
- 辅助研究是与主临床研究并行或随后进行的.
- 来自EHR临床,EHR计费和医疗保健索赔的数据与临床试验数据进行比较.
- 预计将采用健康七级 (HL7) 快速医疗互操作资源 (FHIR®) 标准来提取数据.
主要成果:
- 目前正在进行EHR临床数据的质量评估.
- 目前正在进行EHR计费数据的质量评估.
- 链接医疗保健索赔数据的质量评估正在进行中.
- 对传统临床试验数据的比较分析正在多个治疗领域进行中.
结论:
- 该ACE-RWD计划将为各种RWD来源的相对质量提供见解.
- 调查结果将为在监管提交和批准后研究中适当使用RWD提供信息.
- 这项研究支持"21世纪治疗法"的目标,即利用现实世界的证据来现代化监管途径.
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