植入式骶神经刺激系统临床试验技术审评要求

doi:10.3969/j.issn.1006-9771.2019.04.023

《中国康复理论与实践》 ›› 2019, Vol. 25 ›› Issue (4): 493-496.doi: 10.3969/j.issn.1006-9771.2019.04.023

• 康复管理 • 上一篇

植入式骶神经刺激系统临床试验技术审评要求

张宇晶¹, 廖利民², 李卫³, 阎小妍⁴, 刘晓燕¹, 许伟¹

1.国家药品监督管理局医疗器械技术审评中心，北京市 100081
2.中国康复研究中心北京博爱医院，北京市 100068
3.国家心血管病中心中国医学科学院阜外医院医学研究统计中心，北京市 100037
4.北京大学临床研究所,北京市 100191

收稿日期:2019-01-30 修回日期:2019-03-07 出版日期:2019-04-20 发布日期:2019-04-24
通讯作者: 许伟，E-mail: xuwei@cmde.org.cn
作者简介:张宇晶(1975-)，女，汉族，黑龙江大庆市人，硕士研究生，高级工程师，主要研究方向：有源医疗器械技术审评研究。

Requirements of Technical Review for Clinical Trial for Implantable Sacral Nerve Stimulation System

ZHANG Yu-jing¹, LIAO Li-min², LI Wei³, YAN Xiao-yan⁴, LIU Xiao-yan¹, XU Wei¹

1.Center For Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China
2.China Rehabilitation Research Center, Beijing 100068, China
3.Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, Chinese Academy of Medical Diseases, Fuwai Hospital, Beijing 100037, China
4.Peking University Clinical Research Institute, Beijing 100191, China

Received:2019-01-30 Revised:2019-03-07 Published:2019-04-20 Online:2019-04-24
Contact: XU Wei, E-mail: xuwei@cmde.org.cn

摘要/Abstract

摘要： 在植入式骶神经刺激系统临床试验的技术审评中，应主要关注以下方面：临床试验基本原则、临床试验医疗机构要求和临床试验方案设计要素。

关键词: 植入式骶神经刺激系统, 临床试验, 技术审评

Abstract: The technical review for clinical trials of implantable sacral nerve stimulation system needs to focus on the basic principles of trials, clinical institutition and design elements of clinical trial protocols.

Key words: implantable sacral nerve stimulation system, clinical trail, technical review

中图分类号:

R694

张宇晶, 廖利民, 李卫, 阎小妍, 刘晓燕, 许伟. 植入式骶神经刺激系统临床试验技术审评要求[J]. 《中国康复理论与实践》, 2019, 25(4): 493-496.

ZHANG Yu-jing, LIAO Li-min, LI Wei, YAN Xiao-yan, LIU Xiao-yan, XU Wei. Requirements of Technical Review for Clinical Trial for Implantable Sacral Nerve Stimulation System[J]. 《Chinese Journal of Rehabilitation Theory and Practice》, 2019, 25(4): 493-496.

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植入式骶神经刺激系统临床试验技术审评要求

Requirements of Technical Review for Clinical Trial for Implantable Sacral Nerve Stimulation System

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