Liver biopsy sample evaluation is an essential part of clinical studies in nonalcoholic steatohepatitis (NASH) and is key in excluding confounding morbidities. Current scoring systems, which are decisive for study inclusion, rely on imprecisely defined histological features, leading to a high observer variability of disease categorization. In this News & Views, measures to overcome these limitations are discussed.
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The authors thank the members of the international liver pathology group the “Gnomes” for providing their invaluable input before drafting this article.
P.S. and T.L. are involved in centralized liver biopsy evaluation in clinical studies (Dr. Falk Pharma GmbH).
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Longerich, T., Schirmacher, P. Determining the reliability of liver biopsies in NASH clinical studies. Nat Rev Gastroenterol Hepatol 17, 653–654 (2020). https://doi.org/10.1038/s41575-020-00363-8