| 引用本文: | 李培,陈玉文.FDA以电子健康档案作为真实世界数据的监管考虑[J].中国现代应用药学,2023,40(10):1411-1415. |
| LI Pei,CHEN Yuwen.FDA’s Regulatory Considerations for Electronic Health Records as Real-world Data[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(10):1411-1415. |
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| 摘要: |
| 电子健康档案作为真实世界数据的重要组成部分,目前广泛用于安全性研究,并逐渐用于有效性研究。本文系统介绍了美国食品药品监督管理局对研究者在临床研究中使用电子健康档案数据作为真实世界数据支持药物监管决策时的相关考虑,以期为中国电子健康档案数据作为真实世界数据在药物研发与注册方面的应用提供参考和借鉴。 |
| 关键词: 电子健康档案 美国食品药品监督管理局 临床研究 真实世界数据 药物监管决策 |
| DOI：10.13748/j.cnki.issn1007-7693.20222436 |
| 分类号:R95 |
| 基金项目: |
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| FDA’s Regulatory Considerations for Electronic Health Records as Real-world Data |
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LI Pei1, CHEN Yuwen1,2
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1.Shenyang Pharmaceutical University, School of Business Administration,, Shenyang 110016, China;2.Shenyang Pharmaceutical University, Research Institute of Drug Regulatory Science(Drug Regulatory Research Base of NMPA), Shenyang 110016, China
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| Abstract: |
| As an important part of real-world data, electronic health record is widely used in safety research and gradually used in effectiveness research. This article systematically introduces the FDA's considerations when researchers use electronic health record as real-world data to support drug regulatory decision-making in clinical research, with a view to providing reference for the application of electronic health record as real-world data in drug development and registration in China. |
| Key words: electronic health record(EHR) Food and Drug Administration(FDA) clinical research real-world data drug regulatory decision-making |
