Open AccessLow real-world eligibility rates for nonalcoholic steatohepatitis patients for phase 3 clinical trial criteria application in a large academic health system
Author(s) -
Ysabel C. IlaganYing,
Jin Xu,
Joseph K. Lim,
Albert Do
Publication year - 2020
Publication title -
european journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.881
H-Index - 102
eISSN - 1473-5687
pISSN - 0954-691X
DOI - 10.1097/meg.0000000000001758
Subject(s) - medicine , obeticholic acid , liver biopsy , cirrhosis , nonalcoholic fatty liver disease , cohort , clinical trial , generalizability theory , gastroenterology , biopsy , fatty liver , disease , receptor , agonist , statistics , mathematics
Nonalcoholic steatohepatitis (NASH) is the most common liver disease in the USA. Clinical trials have stringent study criteria which may limit real-world generalizability. Thus, we studied whether a real-world, university-based cohort of patients could be eligible for a pivotal phase 3 NASH clinical trial.