title: Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program.
abstract: Surrogate endpoints for clinical proof of concept (POC) trials in nonalcoholic steatohepatitis (NASH) are based upon expert pathological review of liver biopsies. During early development, these long-term POC studies (≥48 weeks) add cost and time to the "Go/No Go" decision process. However, it is possible to conduct short-term noninvasive POC studies utilizing biomarkers and magnetic resonance imaging. Here, we discuss the use of shorter noninvasive POC studies relative to biopsy-driven studies for drug development in NASH.
authors.affiliation: Covance Clinical Development Services, Princeton, New Jersey, USA.
authors.forename: R N
authors.initials: RN
authors.lastname: Williams
authors.affiliation: Covance Clinical Development Services, Maidenhead, UK.
authors.forename: C
authors.initials: C
authors.lastname: Filozof
authors.affiliation: Covance Clinical Development Services, Princeton, New Jersey, USA.
authors.forename: B J
authors.initials: BJ
authors.lastname: Goldstein
authors.affiliation: Division of Endocrinology, Diabetes, and Metabolism, University of Florida, Department of Medicine, University of Florida, Gainesville, Florida, USA.
authors.forename: K
authors.initials: K
authors.lastname: Cusi
mesh_terms: D015415:Biomarkers; D001706:Biopsy; D002986:Clinical Trials as Topic; D017322:Clinical Trials, Phase II as Topic; D023381:Endpoint Determination; D006801:Humans; D008099:Liver / Q000473:pathology; D008279:Magnetic Resonance Imaging; D065626:Non-alcoholic Fatty Liver Disease / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D012107:Research Design
chemical_list: D015415:Biomarkers