1.Methodological considerations in the design of clinical trial for innovative hepatitis B drugs
Yuanyuan KONG ; Xiaoqing LIU ; Hong YOU ; Jidong JIA ; Pei HU ; Sheinchung CHOW ; Chen YAO
Chinese Journal of Hepatology 2020;28(8):658-661
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.
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