Evaluation of clinical endpoints in new drug research and development for nonalcoholic steatohepatitis
DOI:10.3969/j.issn.1001-5256.2021.06.003
- VernacularTitle:非酒精性脂肪性肝炎新药研发临床终点评价
- Author:
Xiaofei TONG
1
;
Yameng SUN
;
Hong YOU
Author Information
1. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing 100050, China
- Publication Type:Research Article
- Keywords:
Non-alcoholic Fatty Liver Disease;
Drug Discovery;
Clinical Trial
- From:
Journal of Clinical Hepatology
2021;37(6):1249-1253
- CountryChina
- Language:Chinese
-
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.
