人工髋关节假体临床试验设计探讨  

Discussion on Clinical Trial Design of Artificial Hip Prosthesis

作　　者：张家振 刘斌[1] 翟豹 闵玥 刘英慧 张世庆[1] ZHANG Jiazhen;LIU Bin;ZHAI Bao;MIN Yue;LIU Yinghui;ZHANG Shiqing(Center for Medical Device Evaluation,CFDA,Beijing,100081)

机构地区：[1]国家食品药品监督管理总局医疗器械技术审评中心,北京市100081

出　　处：《中国医疗器械杂志》2018年第4期262-264,共3页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划课题(2016YFB1101105)

摘　　要：近年来,人工髋关节假体注册申报的产品逐年增多。在新版医疗器械注册管理办法出台后,境内或进口的此类产品在注册申报时均有可能需要进行规范的临床试验,如何进行科学的临床试验设计是企业和临床试验机构共同关注的问题。该文通过查阅此类产品注册法规、指导原则、国内外公开资料,梳理了人工髋关节临床试验设计的重点问题,主要集中在入选标准、评价标准、样本量计算方面,通过讨论并提供建议,以期对该类产品的临床试验设计提供指导。Recently,the registration of artificial hip prosthesis products increased year by year.In the new version of the provisions for medical device registration,the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country.How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions.To review the guideline and literature concerning registration for artificial hip prosthesis,the focus on clinical trial design of artificial hip prosthesis include clinical inclusion,evaluation standard,sample size.Through the discussion,we hope to provide advice and guidance for clinical trials of this kind of products.

关 键 词：人工髋关节假体 临床试验设计 评价标准 样本量 

分 类 号：F203[经济管理—国民经济]