摘要
布鲁氏菌IgM/IgG抗体检测试剂属于体外诊断试剂,该类试剂需向国家药品监督管理局提交相关技术资料进行注册申报,获得医疗器械注册证后方可在医疗机构使用。按照法规要求,该类试剂应通过临床试验路径开展临床评价,以证明其安全性和有效性。如何科学合理地开展临床试验对于该类试剂的注册申报至关重要。为了指导申请人能够科学地设计和开展临床试验,基于笔者对于该类试剂的技术审评经验,本文对该类试剂注册临床试验时应关注的重点问题,包括临床试验机构选择、对比方法的选择、样本量和统计分析等要点进行了解析。
Brucella IgM/IgG antibody detection reagents belong to in vitro diagnostic reagents,and such reagents need to submit relevant technical evaluation data to NMPA for registration and subsequent application,and to obtain medical device registration certificate before use in medical institutions.According to regulatory requirements,such reagents should be clinically evaluated through clinical trial pathways to prove their safety and effectiveness.It is very important for research of how to carry out clinical trials scientifically and reasonably for the registration and declaration of such reagents.In order to guide the applicant to design and carry out clinical trials scientifically,also based on the author’s experience in technical review of this type of reagents,the key issues that should be paid attention to in the registration of clinical trials of these reagents,including the selection of clinical trial institutions,the selection of comparison methods,sample size and statistical analysis are summarized in this paper.
作者
方丽
何静云
徐超
FANG Li;HE Jingyun;XU Chao(Center for Medical Device Technology Evaluation NMPA,Beijing 100081,China)
出处
《标记免疫分析与临床》
CAS
2024年第2期374-377,共4页
Labeled Immunoassays and Clinical Medicine
关键词
布鲁氏菌
抗体检测
临床试验
Brucella
Antibody detection reagents
Clinical trial
