非酒精性脂肪性肝炎治疗药物临床试验指南解读

Interpretation of clinical trial guidelines for nonalcoholic steatohepatitis

2019年12月,我国国家药品监督管理局发布了《非酒精性脂肪性肝炎治疗药物临床试验指导原则(试行)》,该指导原则主要针对非酒精性脂肪性肝炎伴有显著肝纤维化及代偿期肝硬化(F2~4)的成人患者,介绍了临床试验的终点、总体设计、不同具体研发阶段以及安全性等方面的考虑。同时结合美国以及欧盟的相关指导原则,尝试探讨临床试验与实践的关系。

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.