Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials
BA Davison, SA Harrison, G Cotter, N Alkhouri… - Journal of …, 2020 - Elsevier
Background & Aims Liver biopsies are a critical component of pivotal studies in non-
alcoholic steatohepatitis (NASH), constituting inclusion criteria, risk stratification factors and
endpoints. We evaluated the reliability of NASH Clinical Research Network scoring of liver
biopsies in a NASH clinical trial. Methods Digitized slides of 678 biopsies from 339 patients
with paired biopsies randomized into the EMMINENCE study–examining a novel insulin
sensitizer (MSDC-0602K) in NASH–were read independently by 3 hepatopathologists …
alcoholic steatohepatitis (NASH), constituting inclusion criteria, risk stratification factors and
endpoints. We evaluated the reliability of NASH Clinical Research Network scoring of liver
biopsies in a NASH clinical trial. Methods Digitized slides of 678 biopsies from 339 patients
with paired biopsies randomized into the EMMINENCE study–examining a novel insulin
sensitizer (MSDC-0602K) in NASH–were read independently by 3 hepatopathologists …