Interpretation of clinical trial guidelines for nonalcoholic steatohepatitis
DOI:10.3969/j.issn.1001-5256.2021.06.002
- VernacularTitle:非酒精性脂肪性肝炎治疗药物临床试验指南解读
- Author:
Huiying RAO
1
;
Lai WEI
Author Information
1. Department of Hepatology, Peking University People’s Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing International Cooperation Base for Science and Technology on NAFLD Diagnosis, Beijing 100044, China
- Publication Type:Research Article
- Keywords:
Non-alcoholic Fatty Liver Disease;
Drug Discovery;
Clinical Trial;
Practice Guideline
- From:
Journal of Clinical Hepatology
2021;37(6):1245-1248
- CountryChina
- Language:Chinese
-
Abstract:
In December 2019, National Medical Products Administration of China issued Guidelines for Clinical Trials of Drugs for Treatment of Nonalcoholic Steatohepatitis (Interim), which mainly targeted at adult patients with nonalcoholic steatohepatitis with significant liver fibrosis and compensated liver cirrhosis (F2-F4). This article introduces related considerations from the aspects of clinical trial endpoint, overall clinical trial design, specific research and development stages, and safety. With reference to related guidelines of the United States and the European Union, this article attempts to explore the association between clinical trial and clinical practice.
