Evidence map›Paper›PMID 36894650›Full record

ReviewNature medicine2023

Challenges and opportunities in NASH drug development.

Stephen A Harrison, Alina M Allen, Julie Dubourg, Mazen Noureddin, Naim Alkhouri

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 175 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
175citing papers in PubMed, 5 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

175 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  6. Digital quantitation of bridging fibrosis and septa reveals changes in natural history and treatment not seen with conventional histology.Liver international : official journal of the International Association for the Study of the Liver · 2024
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115 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

5 authors.

Stephen A HarrisonRadcliffe Department of Medicine, University of Oxford, Oxford, UK. stephenharrison87@gmail.com.ORCID http://orcid.org/0000-0001-8285-2204
Alina M AllenDivision of Gastroenterology and Hepatology, Mayo Clinic Rochester, Rochester, MN, USA.
Julie DubourgSummit Clinical Research, San Antonio, TX, USA.ORCID http://orcid.org/0000-0002-5514-8075
Mazen NoureddinHouston Methodist Hospital, Houston, TX, USA.
Naim AlkhouriDepartment of Hepatology, Arizona Liver Health, Chandler, AZ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nonalcoholic fatty liver disease (NAFLD) and its more severe form, nonalcoholic steatohepatitis (NASH), represent a growing worldwide epidemic and a high unmet medical need, as no licensed drugs have been approved thus far. Currently, histopathological assessment of liver biopsies is mandatory as a primary endpoint for conditional drug approval. This requirement represents one of the main challenges in the field, as there is substantial variability in this invasive histopathological assessment, which leads to dramatically high screen-failure rates in clinical trials. Over the past decades, several non-invasive tests have been developed to correlate with liver histology and, eventually, outcomes to assess disease severity and longitudinal changes non-invasively. However, further data are needed to ensure their endorsement by regulatory authorities as alternatives to histological endpoints in phase 3 trials. This Review describes the challenges of drug development in NAFLD-NASH trials and potential mitigating strategies to move the field forward.

Indexed as

Non-alcoholic Fatty Liver DiseaseDrug DevelopmentHumansLiverLiver CirrhosisSeverity of Illness Index

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.