Low real-world eligibility rates for nonalcoholic steatohepatitis patients for phase 3 clinical trial criteria application in a large academic health system.
Ilagan-Ying YC, Xu J, Lim JK, Do A. Low real-world eligibility rates for nonalcoholic steatohepatitis patients for phase 3 clinical trial criteria application in a large academic health system. European Journal Of Gastroenterology & Hepatology 2020, 33: 424-429. PMID: 32433419, PMCID: PMC7674230, DOI: 10.1097/meg.0000000000001758.Peer-Reviewed Original ResearchConceptsUniversity-based cohortNonalcoholic steatohepatitisEnrollment criteriaLiver biopsyClinical trialsHealth system's electronic medical recordDiagnosis of NASHSystem's electronic medical recordGlobal phase 3Obeticholic acid treatmentPivotal phase 3Trial enrollment criteriaLarge academic health systemCommon liver diseaseNonalcoholic steatohepatitis patientsMultiple logistic regressionReal-world populationAcademic health systemPhase 3Electronic medical recordsMedical comorbiditiesReal-world generalizabilitySteatohepatitis patientsLaboratory abnormalitiesNASH patients