Interpretation of clinical trial guidelines for nonalcoholic steatohepatitis / 临床肝胆病杂志

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.