In order to improve the scientificity and standardization of clinical trials of in vitro diagnostic reagents,based on the author's experience in technical review and clinical inspection of such products,taking the clinical trial of in vitro diagnostic reagents in Shanghai as an example,this paper summarizes the existing problems from three aspects:filing review,technical review,and clinical inspection,and provides improvement suggestions for all parties involved in clinical trials of in vitro diagnostic reagents and regulator.
in vitro diagnostic reagentclinnical trialsregistration application
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