Clinical trials of investigational new drugs for nonalcoholic steatohepatitis:challenges in design and practice / 临床肝胆病杂志

ABSTRACT

Research and development of investigational new drugs for nonalcoholic fatty liver disease is now a research hotspot in the field of liver disease. However,there are still great challenges in protocol design and implementation in phase Ⅱ/ Ⅲ clinical trials. Since there are still controversies over the exact histological definition of nonalcoholic steatohepatitis in the academic world and a lack of long - term large -scale studies on the natural history and clinical pathology of nonalcoholic fatty liver disease/ nonalcoholic steatohepatitis,we still face a lot of challenges in the selection and definition of study population,selection of study endpoints,and interpretation of true clinical value. In addi-tion,such clinical trials often have various confounding factors,which should be controlled as much as possible in protocol design and imple-mentation,in order to minimize the bias in research conclusions.