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Peer-Reviewed Publication
J Pathol Inform2026;20100542.January 1, 2026Journal Article

Applications and challenges of utilizing digital pathology and AI-enabled workflows in clinical trials.

Manu Sebastian1, Harsh Batra2, Monika Lamba Saini3, Staci Kearney4, Lorcan Sherry5, Serge Alexanian6, Michael Cohen7, William Weber8, Joe Lennerz9, Anil V Parwani10
1The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States of America.
2McMaster University, Hamilton L8S 4L8, Canada.
3ADC Therapeutics, Imperial College, White City Campus, London W12 0BZ, UK.
4Elevation Strategic Development, 7314 Rossman Gulch Rd, Morrison, CO 8046, United States of America.
5OracleBio Limited, Biocity Scotland, North Lanarkshire ML1 5UH, UK.
6Pictor Labs, Los Angeles, CA 90064, United States of America.
7Wake Forest University School of Medicine, Bowman Gray Center for Medical Education, 475 Vine Street, Winston-Salem, NC 27101, United States of America.
8Takeda, 650 E Kendall St, Cambridge, MA 02142, United States of America.
9BostonGene, University Office Park III, 95 Sawyer Road, Waltham, MA 02453, United States of America.
10Wexner Medical Center, Ohio State University, 410 W 10th Ave, Columbus, OH 43210, United States of America.

Abstract

This is a comprehensive review on current utilization and challenges of digital pathology adoption in clinical trials and aims to provide a broad view on its impact on pathology review processes in clinical trials. It provides an overview of current pathology review practices in clinical trials and unique advantages digital pathology adoption can offer. The key areas including existing workflows,…

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