临床肝胆病杂志2017，Vol.33Issue(12)：2292-2295,4.DOI:10.3969/j.issn.1001-5256.2017.12.007
非酒精性脂肪性肝炎新药临床试验:设讣和实践中的挑战
Clinical trials of investigational new drugs for nonalcoholic steatohepatitis:challenges in design and practice
摘要
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.关键词
非酒精性脂肪性肝炎/临床试验/药物设计Key words
nonalcoholic steatohepatitis/clinical trial/drug design分类
医药卫生引用本文复制引用
茅益民..非酒精性脂肪性肝炎新药临床试验:设讣和实践中的挑战[J].临床肝胆病杂志,2017,33(12):2292-2295,4.基金项目
十三五科技重大专项(2017ZX09304016) （2017ZX09304016）
国家自然科学基金(81670524) （81670524）
上海交通大学医学院多中心临床研究项目资助 （）
上海申康医院发展中心临床创新三年行动计划资助 （）
