人工髋关节假体临床试验设计探讨
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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.
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.
引文
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[3]国家食品药品监督管理总局.医疗器械注册管理办法[EB/OL].[2014-07-30].http://www.sda.gov.cn/WS01/CL0053/103756.html
[4]国家食品药品监督管理总局.髋关节假体系统注册技术审查指导原则(2017年第23号)[EB/OL].[2017-02-10].http://www.sfda.gov.cn/WS01/CL0087/169618.html.
[5]国家食品药品监督管理总局.医疗器械临床试验质量管理规范(局第25号)[EB/OL].[2016-03-01].http://www.sda.gov.cn/WS01/CL0053/148101.html.
[6]国家食品药品监督管理总局.医疗器械临床试验设计指导原则(2018年第6号通告)[EB/OL].[2018-01-04].http://www.sfda.gov.cn/WS01/CL0087/221976.html.
[7]毛宾尧,庞清江,吕厚山.人工髋关节外科学(第二版)[M].北京:人民卫生出版社,2009.
[8]郭卫,姬涛,杨毅.骨盆转移瘤外科治疗的方法及疗效分析[J].中华骨与关节外科杂志,2015,2(1):49-55.
[9]Guidance for Industry and FDA Staff:Clinical data presentations for orthopedic device applications[EB/OL].[2018-01-22].CDRH,FDA.https://www.fda.gov.
[10]郑青山,孙瑞元,陈志扬.新药临床非劣性及等效性试验中的例数估计和等效标准[J].中国新药杂志,2003,6(5):368-371.
[11]成琪,刘玉秀,陈林.单组临床试验目标值法的精确样本含量估计及统计推断[J].中国临床药理学与治疗学,2011,5(5):517-522.
[12]周毅.人工髋关节置换术治疗髋关节骨折81例临床效果分析[J].临床医学,2014,34(11):100-101.
[13]甄平.成人期股骨头骨骺滑脱症的全髋关节置换[J].中国矫形外科杂志,2017,25(5):389-394.
[2]王俏杰,张先龙.人工髋关节置换术的现状与热点[J].中华关节外科杂志,2015(6):718-724.
[3]国家食品药品监督管理总局.医疗器械注册管理办法[EB/OL].[2014-07-30].http://www.sda.gov.cn/WS01/CL0053/103756.html
[4]国家食品药品监督管理总局.髋关节假体系统注册技术审查指导原则(2017年第23号)[EB/OL].[2017-02-10].http://www.sfda.gov.cn/WS01/CL0087/169618.html.
[5]国家食品药品监督管理总局.医疗器械临床试验质量管理规范(局第25号)[EB/OL].[2016-03-01].http://www.sda.gov.cn/WS01/CL0053/148101.html.
[6]国家食品药品监督管理总局.医疗器械临床试验设计指导原则(2018年第6号通告)[EB/OL].[2018-01-04].http://www.sfda.gov.cn/WS01/CL0087/221976.html.
[7]毛宾尧,庞清江,吕厚山.人工髋关节外科学(第二版)[M].北京:人民卫生出版社,2009.
[8]郭卫,姬涛,杨毅.骨盆转移瘤外科治疗的方法及疗效分析[J].中华骨与关节外科杂志,2015,2(1):49-55.
[9]Guidance for Industry and FDA Staff:Clinical data presentations for orthopedic device applications[EB/OL].[2018-01-22].CDRH,FDA.https://www.fda.gov.
[10]郑青山,孙瑞元,陈志扬.新药临床非劣性及等效性试验中的例数估计和等效标准[J].中国新药杂志,2003,6(5):368-371.
[11]成琪,刘玉秀,陈林.单组临床试验目标值法的精确样本含量估计及统计推断[J].中国临床药理学与治疗学,2011,5(5):517-522.
[12]周毅.人工髋关节置换术治疗髋关节骨折81例临床效果分析[J].临床医学,2014,34(11):100-101.
[13]甄平.成人期股骨头骨骺滑脱症的全髋关节置换[J].中国矫形外科杂志,2017,25(5):389-394.