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中国医疗器械杂志 2019, Vol. 43 Issue (5) :375-378    DOI: 10.3969/j.issn.1671-7104.2019.05.018
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成人数据外推至儿科人群探讨
刘露,崔馨月,张宇晶,许伟
国家药品监督管理局医疗器械技术审评中心,北京市,100081
The Exploration of Extrapolation of Data from Adults to Pediatric Population
LIU Lu, CUI Xinyue, ZHANG Yujing, XU Wei
Center for Medical Device Evaluation, NMPA, Beijing, 100081

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摘要 儿科用医疗器械不能满足现有的医疗需求,鉴于儿科人群临床试验难以开展,将成人用医疗器械数据外推至儿科人群的 方法,可最大化利用现有数据,减少不必要的儿科临床试验,从而加速儿科用器械的研发和上市,保障儿科用器械的临 床需求。该文介绍了美国相关指南,并从医疗器械技术审评角度探讨我国成人数据外推至儿科人群,以期为促进我国数 据外推的开展提供借鉴。
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关键词数据外推   医疗器械   儿科人群   指导原则     
Abstract: Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.
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Received 2019-03-20;
Corresponding Authors: 许伟     Email: xuwei@cmde.org.cn
About author: 刘露,E-mail: liulu@cmde.org.cn
引用本文:   
刘露,崔馨月,张宇晶,许伟.成人数据外推至儿科人群探讨[J]  中国医疗器械杂志, 2019,V43(5): 375-378
LIU Lu, CUI Xinyue, ZHANG Yujing, XU Wei.The Exploration of Extrapolation of Data from Adults to Pediatric Population[J]  Chinese Journal of Medical Instrumentation, 2019,V43(5): 375-378
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