Selection of endpoints for efficacy in clinical trials of new drugs
LIU Bing-lin
Abstract：Referring to domestic and international drug registration regulations,technical standards and guidelines,this paper analyzes and explains the concepts and types of efficacy endpoints related to selection for endpoints in clinical trial for drugs based on twenty years of experience in drug evaluation and in-depth understanding of technical standards and guidelines of new drug registration.The characteristics of the primary efficacy endpoints and the basic principles of selecting the primary and second endpoints for efficacy in clinical trials for drugs are also discussed and summarized.The problems that need to be considered when selecting the endpoints for efficacy in the clinical trials are explained.This paper illustrates the matters needing attention and problems in the use of several common types of endpoints in clinical trials.
Keywords：new drugsclinical trialsendpoints of efficacyselection of endpointprimary endpointissues to consider
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：8( 2113-2120 )