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CN 22-1108/R
Volume 37 Issue 8
Aug.  2021
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Article Navigation >  Journal of Clinical Hepatology  > 2021  >  37(8): 1948-1952

Difficulties and challenges in the clinical trial of new drugs for nonalcoholic steatohepatitis

DOI: 10.3969/j.issn.1001-5256.2021.08.044
  • 1.

    Research Ward, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China

  • 2.

    Liver Research Center, Beijing Friendship Hospital, Capital Medical University; Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis; National Clinical Research Center for Digestive Diseases, Beijing 100050, China

Research funding:

Project of Beijing Municipal Science & Technology Commission (Z191100007619037);

National Science and Technology Major Project during the 13th Five-Year Plan Period (2018ZX09201016);

Demonstration Construction Units of Beijing Research Wards (BCRW202010)

  • Received Date: 2021-01-01
  • Accepted Date: 2021-01-22
  • Published Date: 2021-08-20
    Abstract
  • The incidence rate of nonalcoholic steatohepatitis (NASH) keeps increasing in recent years, and there is still a lack of effective therapeutic drugs in clinical practice. This article analyzes the difficulties in the clinical trial of new drugs for NASH from the aspects of the heterogeneity of NASH (body weight, sex, age, and metabolic factors), the influence of confounding factors, and the diagnostic consistency of quantitative indicators, and it is pointed out that conducting a stratified analysis, reducing the influence of confounding factors, and improving diagnostic consistency can help to improve the quality of the clinical trials of new drugs for NASH. Combination therapy including lifestyle improvement may be an effective treatment strategy for NASH, and therapies aiming at improving NASH, exerting an anti-fibrosis effect, and obtaining long-term metabolic benefits are the direction for drug research and development in the future.

     

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