Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science-Reference-Cited by-同舟云学术

Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science

Published:2018-02-22 Issue:5 Volume:67 Page:2001-2012
ISSN:0270-9139
Container-title:Hepatology
language:en
Short-container-title:Hepatology

Author:

Siddiqui Mohammad Shadab¹,Harrison Stephen A.²,Abdelmalek Manal F.³,Anstee Quentin M.⁴,Bedossa Pierre⁵,Castera Laurent⁶,Dimick-Santos Lara⁷,Friedman Scott L.⁸,Greene Katherine⁹,Kleiner David E.¹⁰,Megnien Sophie¹¹,Neuschwander-Tetri Brent A.¹²,Ratziu Vlad¹³,Schabel Elmer¹⁴,Miller Veronica⁹,Sanyal Arun J.¹,

Affiliation:

1. Virginia Commonwealth University; Richmond VA

2. Pinnacle Clinical Research; San Antonio TX

3. Division of Gastroenterology & Hepatology; Duke University School of Medicine; Durham NC

4. Institute of Cellular Medicine; Newcastle University; Newcastle Upon Tyne United Kingdom

5. Department of Pathology, Physiology and Imaging; University of Paris Diderot; Clichy France

6. Department of Hepatology, Hôpital Beaujon; Clichy France

7. Center for Drug Evaluation and Research, US Food and Drug Administration; Silver Springs MD

8. Division of Liver Disease, Icahn School of Medicine at Mount Sinai; New York NY

9. Forum for Collaborative Research; University of California Berkeley; Washington DC

10. National Cancer Institute, Center for Cancer Research; Bethesda MD

11. Genfit Corp; Cambridge MA

12. Division of Gastroenterology and Hepatology; Saint Louis University School of Medicine; St. Louis MO

13. Department of Hepatology and Gastroenterology; Hôpital Pitié Salpêtrière et Université Pierre et Marie Curie; Paris France

14. Gastroenterology & Hepatology Unit, Bundesinstitut für Arzneimittel und Medizinprodukte; Bonn Germany

Funder

National Institutes of Health

Intramural Research Program of the National Institutes of Health, National Cancer Institute

Publisher

Wiley

Subject

Hepatology

Reference55 articles.

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3. Fibrosis progression in nonalcoholic fatty liver vs nonalcoholic steatohepatitis: a systematic review and meta-analysis of paired-biopsy studies;Singh;Clin Gastroenterol Hepatol,2015

4. Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting liver transplantation in the United States;Wong;Gastroenterology,2015

5. Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: findings and recommendations from an American Association for the Study of Liver Diseases-U.S. Food and Drug Administration joint workshop;Sanyal;Hepatology,2015

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