Featured Publications
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 ResearchMeSH KeywordsAdultBiopsyCohort StudiesFemaleFibrosisHumansLiver CirrhosisMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseConceptsUniversity-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
2020
Drug development of nonalcoholic fatty liver disease: challenges in research, regulatory pathways, and study endpoints
Do A, Ilagan-Ying YC, Mehal WZ, Lim JK. Drug development of nonalcoholic fatty liver disease: challenges in research, regulatory pathways, and study endpoints. Expert Opinion On Drug Discovery 2020, 16: 125-134. PMID: 33086894, DOI: 10.1080/17460441.2020.1811674.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsClinical Trials as TopicDrug ApprovalDrug DevelopmentDrug DiscoveryEndpoint DeterminationHumansNon-alcoholic Fatty Liver DiseaseObesityResearch DesignConceptsNonalcoholic fatty liver diseaseFatty liver diseaseNonalcoholic steatohepatitisLiver diseaseHealthcare resource burdenNovel trial designsClinical trial researchSignificant healthcareCase definitionClinical trialsEfficacious treatmentNew therapiesEndpoint definitionsTrial designTreatment targetsMetabolic diseasesTrial researchClinical researchDrug development processQuality data reportingDrug approvalDiseaseResource burdenRegulatory pathwaysDrug development