Peer-Reviewed Publication
medRxiv2023April 25, 2023Preprint
AI-based histologic scoring enables automated and reproducible assessment of enrollment criteria and endpoints in NASH clinical trials.
Janani S Iyer1, Harsha Pokkalla1, Charles Biddle-Snead1, Oscar Carrasco-Zevallos1,2, Mary Lin1, Zahil Shanis1, Quang Le1, Dinkar Juyal1, Maryam Pouryahya1,3, Aryan Pedawi1,4, Sara Hoffman1, Hunter Elliott1,5, Kenneth Leidal1,6, Robert P Myers7,8, Chuhan Chung7,9, Andrew N Billin7, Timothy R Watkins7, Murray Resnick1,10, Katy Wack1, Jon Glickman1, Alastair D Burt11, Rohit Loomba12, Arun J Sanyal13, Michael C Montalto1, Andrew H Beck1, Amaro Taylor-Weiner1, Ilan Wapinski1
1PathAI, Boston, MA, USA.
2Affiliation shown is that during the time of study; current affiliation is Johnson & Johnson, New Brunswick, NJ, USA.
3Affiliation shown is that during the time of study; current affiliation is AstraZeneca, Gaithersburg, MD, USA.
4Affiliation shown is that during the time of study; current affiliation is Atomwise, San Francisco, CA, USA.
5Affiliation shown is that during the time of study; current affiliation is BigHat Biosciences, San Mateo, CA, USA.
6Affiliation shown is that during the time of study; current affiliation is Genesis Therapeutics, Burlingame, CA, USA.
7Gilead Sciences, Inc., Foster City, CA, USA.
8Affiliation shown is that during the time of study; current affiliation is OrsoBio, Inc., Palo Alto, CA, USA.
9Affiliation shown is that during the time of study; current affiliation is Inipharm, San Diego, CA, USA.
10Affiliation shown is that during the time of study; current affiliation is Rhode Island Hospital and The Miriam Hospital, Providence, RI, USA.
11Newcastle University, Newcastle, UK.
12NAFLD Research Center, Division of Gastroenterology and Hepatology, University of California at San Diego, San Diego, CA, USA.
13Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, VCU School of Medicine, Richmond, VA, USA.
Abstract
Clinical trials in nonalcoholic steatohepatitis (NASH) require histologic scoring for assessment of inclusion criteria and endpoints. However, guidelines for scoring key features have led to variability in interpretation, impacting clinical trial outcomes. We developed an artificial intelligence (AI)-based measurement (AIM) tool for scoring NASH histology (AIM-NASH). AIM-NASH predictions for NASH…
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