期刊
JOURNAL OF HEPATOLOGY
卷 73, 期 3, 页码 680-693出版社
ELSEVIER
DOI: 10.1016/j.jhep.2020.04.030
关键词
Lifestyle modifications; Placebo effect; Endpoints; Fibrosis; Clinical studies
资金
- 3-V Biosciences
- Abbott Molecular
- AbbVie
- Advanced Biological Laboratories
- Afimmune
- Aicuris
- Allergan
- Aligos Therapeutics
- Altimmune
- AMRA Medical
- Arbutus Biopharma
- Arrowhead Pharmaceuticals
- Assembly Biosciences
- Astellas
- Astra-Zeneca
- Biogen
- Boehringer Ingelheim
- Bristol-Myers Squib
- Celgene
- Chimerix
- Cirius Therapeutics
- Cocrystal Pharma, Inc.
- Conatus Pharmaceuticals, Inc.
- ConSynance
- Covance
- DDL Diagnostics
- CTI Clinical Trial and Consulting Services
- Cirius Therapeutics Inc.
- ContraVir
- Cymabay
- DeuteRx
- DiaPharma
- DS Biopharma
- Durect
- EA Pharma Co., Ltd.
- Echosens
- Eli Lilly and Company
- Enanta Pharmaceuticals, Inc.
- Enyo Pharma
- e.scopics
- Exalenz
- Ferring Pharmaceuticals
- Fractyl
- Galectin Therapeutics
- Genentech
- Genesis Imaging Services
- Genfit
- Genkyotex
- Gilead Sciences
- GlaxoSmithKline
- Glympse Bio
- Hepatitis B Foundation
- HepQuant
- HighTide Therapeutics
- HistoIndex Pte Ltd
- Humedics GmbH
- ICON Clinical Research
- Immuron
- Intercept Pharmaceuticals
- Inventiva
- Ironwood Pharmaceuticals
- Janssen
- LabCorp
- Madrigal Pharmaceuticals
- Mallinckrodt Pharmaceuticals
- MEDIAN Technologies
- MediciNova
- Medivir
- Merck Laboratories
- Metacrine
- Microbiotix
- Mirum
- Morphic Therapeutic
- Mylan
- NGM Biopharmaceuticals
- Nimbus Therapeutics
- Nitto Denko Technical Corp
- Nordic Bioscience
- Northsea Therapeutics
- Novartis
- Novo Nordisk Inc.
- Nusirt
- OWL Metabolomics
- Perspectum Diagnostics
- Pfizer
- Pliant Therapeutics
- PPD Inc.
- ProSciento
- Quest Diagnostics
- Raptor Pharmaceuticals
- Resonance Health
- Resoundant
- Roche Molecular Systems
- Roivant Sciences
- RuiYi
- SeraCare
- Shire
- Springbank Pharma
- Somalogic
- Syneos Health
- Takeda
- TARGET PharmaSolutions
- Teva Pharmaceuticals
- ViiV Healthcare
- VLVBio
- Zafgen
- Zealand Pharma
- Duke Division of Gastroenterology
- Duke Division of Integrative Medicine
- NIH [U01DK061713]
Lifestyle modification is the foundation of treatment recommendations for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The design of clinical trials in NASH may be impeded by the lack of a systematic approach to identify and evaluate how lifestyle changes and/or modifications influence clinical trial outcomes and associated endpoints. Furthermore, there are additional uncertainties regarding the methods that can be utilised to better characterise and quantify lifestyle variables - which can influence disease activity and alter trial endpoints - to allow for comparisons of trial outcomes across different phases of research and/or within drug-classes. This summary by the Liver Forum's Standard of Care Working Group reviews currently available clinical data, identifies the barriers and challenges associated with the standard of care in NAFLD/NASH clinical trials, defines available assessments of lifestyle changes, and proposes approaches to better understand and define the influence of diet and exercise on NASH treatment in the context of different pharmacologic interventions. The ultimate objective is to propose tangible solutions which enable investigators, sponsors, and regulatory authorities to meaningfully interpret clinical trial outcomes and the impact of lifestyle modification on such outcomes as they pertain to phase I-IV clinical trials. (C) 2020 Published by Elsevier B.V. on behalf of European Association for the Study of the Liver.
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