biostudies-literatureSiddiqui MSNIDDK NIH HHSNational Institutes of Health2001-2012https://www.ebi.ac.uk/biostudies/studies/S-EPMC5906171biostudies-literatureUnknown67(5)Nonalcoholic steatohepatitis (NASH) is an important cause of liver-related morbidity and mortality. There are no approved therapies, and the results of clinical trials have been difficult to compare due to inconsistent definitions of relevant disease parameters in patients with NASH. The natural course of the disease has not been rigorously characterized, particularly with respect to the contributions of underlying obesity, type 2 diabetes, and other comorbidities and the treatments provided for these comorbidities. Efforts to perform analyses of pooled data are limited by heterogeneous case definitions used across studies to define disease states. There remains a major unmet need in the field to develop standardized definitions for populations for interventional trials. Such definitions aHepatology (Baltimore, Md.)Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science.PMC5906171R01 DK105961RO1 DK 10596Ratziu VSchabel EFriedman SLLiver Forum Case Definitions Working GroupMiller VKleiner DESiddiqui MSHarrison SAAnstee QMDimick-Santos LNeuschwander-Tetri BASanyal AJAbdelmalek MFGreene KMegnien SBedossa PCastera LfalseCase definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science.Nonalcoholic steatohepatitis (NASH) is an important cause of liver-related morbidity and mortality. There are no approved therapies, and the results of clinical trials have been difficult to compare due to inconsistent definitions of relevant disease parameters in patients with NASH. The natural course of the disease has not been rigorously characterized, particularly with respect to the contributions of underlying obesity, type 2 diabetes, and other comorbidities and the treatments provided for these comorbidities. Efforts to perform analyses of pooled data are limited by heterogeneous case definitions used across studies to define disease states. There remains a major unmet need in the field to develop standardized definitions for populations for interventional trials. Such definitions a2018-01-01T00:00:00Z2018 May2025-04-26T11:20:47.185Z2019-03-26T23:37:34ZS-EPMC59061712905945610.1002/hep.29607