Manu Sebastian, Harsh Vardhan Batra, Monika Saini, Staci J. Kearney, Lorcan Sherry, Serge Alexanian, Michael Cohen, William Weber, Joe Lennerz, Anil V. Parwani
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, use case scenarios in different disease areas in clinical trials, including but not limited to patient identification and pre-screening, and regulatory aspects have been described with relevance. In addition, the review delves into the integration of genomics, AI, image analysis, radiology, and advanced computational pathology, to propose measures to enhance clinical trial outcomes. The current regulatory landscape around digital pathology adoption and potential future advancements in this field are also discussed as appropriate.