High rates of ineligibility for participation in trials of new therapies in non-alcoholic steatohepatitis: a systematic review.

European Journal of Gastroenterology & Hepatology
Anna RoskillyIan A Rowe

Abstract

Non-alcoholic fatty liver disease is common and there are a number of treatments in development. Patients with non-alcoholic steatohepatitis (NASH) and significant fibrosis are thought to be the population most in need of treatment. Identification of this group requires liver biopsy. The aim of this study was to identify the proportion of patients screened for phase 2 randomised controlled trials who subsequently entered these studies. Large, multicentre, phase 2 randomised controlled trials of pharmacological therapies for NASH were identified by systematic review. The pooled proportion of potential participants who entered the trials was estimated by meta-analysis. The reasons for trial ineligibility were separately extracted and analysed. Thirteen reports of 14 trials were included. Overall, there were 4014 screened individuals included in the quantitative analyses and 53% were subsequently enrolled in a trial. Considering trials in which the entry criteria matched the current paradigm for treatment, that is, the presence of NASH and significant fibrosis, only 35% of screened individuals were eligible for trial entry. More than half of ineligible individuals were excluded on the basis of liver histology most often due to ins...Continue Reading

References

Sep 14, 1999·The American Journal of Gastroenterology·E M BruntB R Bacon
Sep 6, 2003·BMJ : British Medical Journal·Julian P T HigginsDouglas G Altman
Mar 5, 2004·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Keith D LindorPatrick Colin
May 26, 2005·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·David E KleinerUNKNOWN Nonalcoholic Steatohepatitis Clinical Research Network
Jul 22, 2009·PLoS Medicine·David MoherUNKNOWN PRISMA Group
Apr 30, 2010·The New England Journal of Medicine·Arun J SanyalUNKNOWN NASH CRN
Aug 5, 2010·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Ulrich F H LeuschnerUNKNOWN NASH Study Group
Jul 13, 2011·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Claudia O ZeinArthur J McCullough
Apr 23, 2014·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Pierre Bedossa, UNKNOWN FLIP Pathology Consortium
Aug 16, 2014·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Mattias EkstedtRolf Hultcrantz
Dec 9, 2014·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Rohit LoombaUNKNOWN San Diego Integrated NAFLD Research Consortium (SINC)
Jan 6, 2015·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Arun J SanyalUNKNOWN United States Food and Drug Administration
Mar 11, 2015·Journal of Clinical and Experimental Hepatology·Kotacherry T ShenoyAngelo A Bignamini
Dec 29, 2015·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Zobair M YounossiMark Wymer
Aug 24, 2017·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Scott L FriedmanEric Lefebvre
Sep 12, 2017·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Rohit LoombaUNKNOWN GS-US-384-1497 Investigators
Dec 1, 2017·Nature Reviews. Gastroenterology & Hepatology·Ian A Rowe
Jul 11, 2018·Gastroenterology·Stephen A HarrisonUNKNOWN GS-US-321-0105 and GS-US-321-0106 Investigators

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Citations

Mar 13, 2021·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Ian A RoweRohit Loomba

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