Evidence map›Paper›PMID 25557690›Full record

GuidelineHepatology (Baltimore, Md.)2015

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.

Arun J Sanyal, Scott L Friedman, Arthur J McCullough, Lara Dimick-Santos, American Association for the Study of Liver Diseases, United States Food and Drug Administration

Registry-linked trialAbstract readPractice Guideline
PubMed Full text at PMC Publisher
In one paragraph

Guideline in Hepatology (Baltimore, Md.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03294850 (Evaluation of Biomarkers to Quantify Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis at Baseline and Following Bariatric Surgery), which is not on this map. Cited by 165 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
165citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03294850 nacompletednot on this mapstarted 2018, after this paper: background citation

Evaluation of Biomarkers to Quantify Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis at Baseline and Following Bariatric Surgery (BARI)

TypeinterventionalSponsorAdventHealth Translational Research InstituteRan2018 to 2020Enrolled14ConditionsNASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver DiseaseArmsBariatric surgery, HepQuant SHUNT Dual Cholate Liver Diagnostic Kit
3 · Its place in the literature

Who cites it

165 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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105 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Arun J SanyalDivision of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA.
Scott L Friedman
Arthur J McCullough
Lara Dimick-Santos
American Association for the Study of Liver Diseases
United States Food and Drug Administration

Funding

Molecular Determinants of Disease Progression in Nonalcoholic SteatohepatitisR01DK081410 · NIDDK · VIRGINIA COMMONWEALTH UNIVERSITY · PI SANYAL, ARUN J · 2009 to 2013
$1.7M
NIDDK NIH HHS R01 DK081410
6 · The paper itself

Abstract

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease (CLD) in North America. It is a growing contributor to the burden of CDL requiring liver transplantation. Cirrhosis is also associated with an increased risk of hepatocellular cancer, which may occur even in the absence of cirrhosis in subjects with nonalcoholic steatohepatitis (NASH), the histological form of NAFLD associated with increased liver-related mortality. The diagnosis of NASH currently requires a liver biopsy. There are also no U.S. Food and Drug Administration (FDA)-approved therapies for NASH. Therefore, there is a need to develop better diagnostic and therapeutic strategies for patients with NASH, targeting both those with early-stage disease as well as those with advanced liver fibrosis. There are unique challenges in the design of studies for these target populations. The long relatively asymptomatic time interval in the progression of NAFLD and NASH to cirrhosis and ultimately liver failure, along with gaps in knowledge regarding disease modifiers, combine to present significant challenges in trial design. Therefore, there is an urgent need to develop methods to identify the populations at particular risk of disease progression and validate endpoints that reflect meaningful changes in health status in this population. This article summarizes the discussion at a joint workshop held September 5 and 6, 2013 in Silver Spring, Maryland, sponsored by the FDA and the American Association for the Study of Liver Diseases to develop guidance on diagnostic and therapeutic modalities for NASH.

Indexed as

BiomarkersClinical Trials as TopicCongresses as TopicDrugs, InvestigationalHumansNon-alcoholic Fatty Liver DiseaseBiomarkersDrugs, Investigational

Identifiers

PMID25557690
PMCPMC4900161

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.