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Peer-Reviewed Publication
Nat Med2024;30(10):2914-2923.October 1, 2024Journal Article

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

Janani S Iyer1,2, Dinkar Juyal1, Quang Le1, Zahil Shanis1, Harsha Pokkalla1, Maryam Pouryahya1,3, Aryan Pedawi1,4, S Adam Stanford-Moore1, Charles Biddle-Snead1, Oscar Carrasco-Zevallos1,5, Mary Lin1,6, Robert Egger1, Sara Hoffman1,7, Hunter Elliott1,8, Kenneth Leidal1,9, Robert P Myers10,11, Chuhan Chung10,12, Andrew N Billin10, Timothy R Watkins10, Scott D Patterson10, Murray Resnick1,13, Katy Wack1, Jon Glickman1,14, Alastair D Burt15, Rohit Loomba16, Arun J Sanyal17, Ben Glass1, Michael C Montalto1,18, Amaro Taylor-Weiner1,2, Ilan Wapinski1,19, Andrew H Beck20
1PathAI, Boston, MA, USA.
2Absci, Vancouver, WA, USA.
3AstraZeneca, Gaithersburg, MD, USA.
4Atomwise, San Francisco, CA, USA.
5Johnson & Johnson, New Brunswick, NJ, USA.
6Supernus Pharmaceuticals, Rockville, MD, USA.
7Harvard Medical School, Boston, MA, USA.
8BigHat Biosciences, San Mateo, CA, USA.
9Genesis Therapeutics, Burlingame, CA, USA.
10Gilead Sciences, Inc., Foster City, CA, USA.
11OrsoBio, Inc., Palo Alto, CA, USA.
12Inipharm, San Diego, CA, USA.
13Rhode Island Hospital and The Miriam Hospital, Providence, RI, USA.
14Massachusetts General Hospital, Boston, MA, USA.
15NIHRB Medical Research Center, Newcastle University, Newcastle, UK.
16NAFLD Research Center, Division of Gastroenterology and Hepatology, University of California at San Diego, San Diego, CA, USA.
17Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, VCU School of Medicine, Richmond, VA, USA.
18Amgen, Thousand Oaks, CA, USA.
19Sanofi Pharmaceuticals, Cambridge, MA, USA.
20PathAI, Boston, MA, USA. andy.beck@pathai.com.

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 pred…

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