Evidence map›Paper›PMID 39112795›Full record

ArticleNature medicine2024

AI-based automation of enrollment criteria and endpoint assessment in clinical trials in liver diseases.

Janani S Iyer, Dinkar Juyal, Quang Le, Zahil Shanis, Harsha Pokkalla, Maryam Pouryahya, Aryan Pedawi, S Adam Stanford-Moore, Charles Biddle-Snead, Oscar Carrasco-Zevallos and 21 more

Registry-linked trialAbstract read
In one paragraph

Article in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03449446 (A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
–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.

NCT03449446 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

TypeinterventionalSponsorGilead SciencesRan2018 to 2019Enrolled395ConditionsNonalcoholic SteatohepatitisArmsSEL, FIR, CILO, Placebo to match FIR, Placebo to match CILO
3 · Its place in the literature

Who cites it

27 citing papers in PubMed.

  1. Article
  2. Review
  3. MAFLD/MASLD: Past, Present, and Future.Journal of gastroenterology and hepatology · 2026
    Review
  4. Review
  5. Drug Development for MASH-Related Compensated Cirrhosis: Past, Present and Future.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. [Diagnosis and treatment of liver diseases in the era of artificial intelligence].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Review
  17. Review
  18. Article
  19. Review
  20. Review
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

31 authors.

Janani S Iyer *PathAI, Boston, MA, USA.
Dinkar Juyal *PathAI, Boston, MA, USA.
Quang Le *PathAI, Boston, MA, USA.
Zahil Shanis *PathAI, Boston, MA, USA.
Harsha PokkallaPathAI, Boston, MA, USA.
Maryam PouryahyaPathAI, Boston, MA, USA.
Aryan PedawiPathAI, Boston, MA, USA.
S Adam Stanford-MoorePathAI, Boston, MA, USA.ORCID http://orcid.org/0000-0002-0689-2607
Charles Biddle-SneadPathAI, Boston, MA, USA.
Oscar Carrasco-ZevallosPathAI, Boston, MA, USA.
Mary LinPathAI, Boston, MA, USA.
Robert EggerPathAI, Boston, MA, USA.
Sara HoffmanPathAI, Boston, MA, USA.
Hunter ElliottPathAI, Boston, MA, USA.
Kenneth LeidalPathAI, Boston, MA, USA.
Robert P MyersGilead Sciences, Inc., Foster City, CA, USA.
Chuhan ChungGilead Sciences, Inc., Foster City, CA, USA.
Andrew N BillinGilead Sciences, Inc., Foster City, CA, USA.
Timothy R WatkinsGilead Sciences, Inc., Foster City, CA, USA.
Scott D PattersonGilead Sciences, Inc., Foster City, CA, USA.ORCID http://orcid.org/0000-0002-9840-4964
Murray ResnickPathAI, Boston, MA, USA.
Katy WackPathAI, Boston, MA, USA.
Jon GlickmanPathAI, Boston, MA, USA.
Alastair D BurtNIHRB Medical Research Center, Newcastle University, Newcastle, UK.
Rohit LoombaNAFLD Research Center, Division of Gastroenterology and Hepatology, University of California at San Diego, San Diego, CA, USA.
Arun J SanyalStravitz-Sanyal Institute for Liver Disease and Metabolic Health, VCU School of Medicine, Richmond, VA, USA.ORCID http://orcid.org/0000-0001-8682-5748
Ben GlassPathAI, Boston, MA, USA.
Michael C MontaltoPathAI, Boston, MA, USA.
Amaro Taylor-WeinerPathAI, Boston, MA, USA.ORCID http://orcid.org/0000-0002-7249-2425
Ilan WapinskiPathAI, Boston, MA, USA.
Andrew H BeckPathAI, Boston, MA, USA. andy.beck@pathai.com.ORCID http://orcid.org/0000-0002-9978-134X

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
Pediatric Trials in Non-Alcoholic Steatohepatitis (NASH)U01DK061734 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ROHIT LOOMBA · 2002 to 2026
$24.4M
Tissue-specific roles of FXR in CVD and NASHP01HL147835 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI EVANS, RONALD M · 2020 to 2024
$12.2M
San Diego Digestive Diseases Research CenterP30DK120515 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Bernd G. Schnabl · 2019 to 2026
$10.8M
HIV MASLD Clinical Research Network (HCRN)R01DK121378 · NIDDK · INDIANA UNIVERSITY INDIANAPOLIS · PI NAGA P CHALASANI, ROHIT LOOMBA · 2020 to 2026
$8.7M
Novel IL-23 inhibitor for the treatment of alcohol associated liver diseaseU01AA029019 · NIAAA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KISSELEVA, TATIANA, LOOMBA, ROHIT · 2020 to 2024
$3.7M
QUS Technology for Diagnosis and Grading of Hepatic Steatosis in NAFLDR01DK106419 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOOMBA, ROHIT, SIRLIN, CLAUDE B · 2015 to 2019
$3.4M
San Diego Cirrhosis Clinical Research NetworkU01DK130190 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ROHIT LOOMBA · 2021 to 2026
$2.3M
Non-invasive screening of diabetics for advanced fibrosis due to NAFLDR01DK124318 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOOMBA, ROHIT · 2020 to 2022
$1.7M
NCATS NIH HHS UL1 TR001442NHLBI NIH HHS P01 HL147835NIAAA NIH HHS U01 AA029019NIDDK NIH HHS P30 DK120515NIDDK NIH HHS R01 DK106419NIDDK NIH HHS R01 DK121378NIDDK NIH HHS R01 DK124318NIDDK NIH HHS U01 DK061734NIDDK NIH HHS U01 DK130190
6 · The paper itself

Abstract

Clinical trials in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis) require histologic scoring for assessment of inclusion criteria and endpoints. However, variability in interpretation has impacted clinical trial outcomes. We developed an artificial intelligence-based measurement (AIM) tool for scoring MASH histology (AIM-MASH). AIM-MASH predictions for MASH Clinical Research Network necroinflammation grades and fibrosis stages were reproducible (κ = 1) and aligned with expert pathologist consensus scores (κ = 0.62-0.74). The AIM-MASH versus consensus agreements were comparable to average pathologists for MASH Clinical Research Network scores (82% versus 81%) and fibrosis (97% versus 96%). Continuous scores produced by AIM-MASH for key histological features of MASH correlated with mean pathologist scores and noninvasive biomarkers and strongly predicted progression-free survival in patients with stage 3 (P < 0.0001) and stage 4 (P = 0.03) fibrosis. In a retrospective analysis of the ATLAS trial (NCT03449446), responders receiving study treatment showed a greater continuous change in fibrosis compared with placebo (P = 0.02). Overall, these results suggest that AIM-MASH may assist pathologists in histologic review of MASH clinical trials, reducing inter-rater variability on trial outcomes and offering a more sensitive and reproducible measure of patient responses.

Indexed as

Artificial IntelligenceClinical Trials as TopicNon-alcoholic Fatty Liver DiseaseAutomationEndpoint DeterminationFemaleHumansLiver CirrhosisLiver DiseasesMalePatient SelectionReproducibility of ResultsRetrospective Studies

Identifiers

PMID39112795
PMCPMC11485234

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.