Evaluation of clinical endpoints in new drug research and development for nonalcoholic steatohepatitis / 临床肝胆病杂志

ABSTRACT

Nonalcoholic steatohepatitis (NASH) has gradually become a common cause of liver cirrhosis, hepatocellular carcinoma, and liver-related deaths, and currently no effective therapeutic drugs have been approved for the treatment of NASH. Therefore, there is an urgent need for effective new drugs to improve clinical endpoints and reduce disease burden. The development and progression of NASH are closely associated with metabolism and have strong heterogeneity, and it takes a long time to observe its clinical outcome. These characteristics bring challenges to the research and development of new drugs for NASH. In the process of drug research and development, the selection of treatment endpoints is crucial to the evaluation of drug efficacy, and the basic principle of endpoint selection is whether it can reflect clinical outcome and predict clinical benefit. This article summarizes and discusses the selection of treatment endpoints at different stages of the research and development of new drugs for NASH.