A Clinical Trial Design Analysis of Brucella IgM/IgG Antibody Detection Reagent
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.
NETL
NSTL
万方数据
维普
