患者登记研究应用于医疗器械监管科学的实践研究与思考

doi:10.19803/j.1672-8629.20220654

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 423-427.
DOI: 10.19803/j.1672-8629.20220654

患者登记研究应用于医疗器械监管科学的实践研究与思考

赵燕¹, 刘文博^2△, 赵一飞¹, 李栋¹, 郑立佳¹, 宋雅娜¹, 赵玉娟^3#, 董放^1,*

¹国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022;
²国家药品监督管理局医疗器械技术审评中心,北京 100081;
³山东省药品不良反应监测中心,山东济南 250021

收稿日期:2022-11-09 出版日期:2023-04-15 发布日期:2023-04-20
通讯作者: ^*董放,男,硕士,高级工程师,医疗器械上市后安全性监测与评价。E-mail：dongfang@cdr-adr.org.cn;^#为共同通信作者。
作者简介:赵燕,女,硕士,高级工程师,医疗器械上市后安全性监测与评价。^△为并列第一作者。
基金资助:
国家重点研发计划（2021YFC2701300、2021YFC27 01302）; 中国药品监管科学行动计划第二批重点项目（[2021] 37-10）

Applicability of patient registry research to regulation of medical devices

ZHAO Yan¹, LIU Wenbo^2△, ZHAO Yifei¹, LI Dong¹, ZHENG Lijia¹, SONG Yana¹, ZHAO Yujuan^3#, DONG Fang^1,*

¹Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
²Center for Medical Device Evaluation, NMPA, Beijing 100081, China;
³Shandong ADR Monitoring Center, Jinan Shandong 250021, China

Received:2022-11-09 Online:2023-04-15 Published:2023-04-20

摘要/Abstract

摘要： 目的结合我国医疗器械监管工作实际,思考我国开展患者登记主动监测实践的可行性和必要性,提出将患者登记作为监测新方法纳入监管科学实践的建议。方法通过查阅文献资料,分析国内外开展的患者登记研究实例,阐述患者登记作为主动监测方法在高风险植入类医疗器械监管决策中的应用。结果患者登记作为一种重要的真实世界数据来源,已经成为获取高风险植入类医疗器械产品真实世界证据的重要工具和方法,为各国监管决策提供关键证据。结论为主动适应医疗器械产业特点和全球化发展趋势,借鉴国外经验,建议将患者登记作为一种主动监测新工具纳入我国医疗器械监管科学实践。

关键词: 患者登记, 医疗器械, 监管科学, 主动监测, 真实世界数据

Abstract: Objective To explore the feasibility and significance of active monitoring of patient registries in the light of actual supervision of medical devices in China, and to propose the incorporation of patient registries into regulatory science as a new method of monitoring. Methods Based on literature review, cases of patient registry research that had been carried out at home and abroad were analyzed and the application of patient registries as a proactive monitoring method in regulatory decision-making for high-risk implantable medical devices was elaborated. Results As an important real-world data source, patient registries have become a useful means and method to gather “real-world” evidence on high-risk implantable medical devices and provide critical evidence for national regulatory decisions. Conclusion In order to become aligned with the characteristics of the medical device industry and trends of globalization, it is recommended that patient registries be incorporated into the science of medical device supervision in China as a new tool for proactive monitoring.

Key words: patient registries, medical device, regulatory science, proactive monitoring, real-world data

中图分类号:

R951

赵燕, 刘文博, 赵一飞, 李栋, 郑立佳, 宋雅娜, 赵玉娟, 董放. 患者登记研究应用于医疗器械监管科学的实践研究与思考[J]. 中国药物警戒, 2023, 20(4): 423-427.

ZHAO Yan, LIU Wenbo, ZHAO Yifei, LI Dong, ZHENG Lijia, SONG Yana, ZHAO Yujuan, DONG Fang. Applicability of patient registry research to regulation of medical devices[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 423-427.

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患者登记研究应用于医疗器械监管科学的实践研究与思考

Applicability of patient registry research to regulation of medical devices

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