Key considerations and issues of assessment for clinical value of drugs
LIU Bing-lin
XUE Fei-ran
Abstract：The clinical value of drugs,R & D and evaluation has been paid more and more attention.This paper summarizes and analyzes the main factors and problems which may influence the evaluation of drugs,clinical values in order to enhance the understanding in R & D and evaluation from the clinical reviewers,view point.It mainly includes the characteristics of the target diseases of drugs,treatment status and current medical development of the target disease,therapeutic aim of drug,objective of the clinical trial and the primary endpoints in the pivotal study and other factors which may influence the clinical values.This paper also discusses the main points in the clinical value evaluation,the following points should be fully considered during the R&D and evaluating of the clinical values for NDA:multiple factors should be considered,not only focus on single factor;clinical value should be supported by data and evidence,not just by announcing the therapeutic aim of drug or the objective of the clinical trial by the registered applicants,and also the relationship between clinical value and the primary endpoints in the pivotal study should be fully concerned.
Keywords：new drugsclinical valuemeaningful therapeutic benefitinfluence factorprimary endpoint
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 504-508 )