The research and development of innovative drugs targeting the clinical cure of chronic hepatitis B has become active in recent years. In the clinical trials of new drugs for hepatitis B, the use of new design concepts, new methods, and new technologies to evaluate the efficacy of innovative drugs is expected to shorten the clinical research process of candidate new drugs and reduce the cost of new drug development. However, the new designs such as seamless adaptive design and master plan design have few practical applications in clinical trials of innovative hepatitis B drugs. This article will focus on the methodological factors in the design of phase II/III clinical trials of innovative hepatitis B drugs, and introduce the key points of the new clinical trial design in order to provide methodological references for the development of innovative hepatitis B drugs.
近年来以慢性乙型肝炎临床治愈为目标的新药研发进入活跃期。在针对乙型肝炎的新药临床试验中，采用设计新理念、新方法、新技术来评价创新药物的疗效，有望缩短候选新药的临床研究过程、降低新药开发成本。但是，无缝适应性设计、主方案设计等新型设计在乙型肝炎创新药物临床试验中的实际应用尚少。现将聚焦乙型肝炎创新药物II/III期临床试验设计的方法学考量，重点介绍临床试验新型设计，以期为乙型肝炎创新药物的研发提供方法学参考。.
Keywords: Chronic hepatitis B; Functional cure; Methodology.