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

## TL;DR

This paper reviews how digital pathology and AI can improve clinical trials by streamlining processes and enhancing outcomes.

## Contribution

The paper provides a comprehensive overview of digital pathology's current use and challenges in clinical trials, emphasizing AI integration and regulatory considerations.

## Key findings

- Digital pathology offers unique advantages in pathology review processes for clinical trials.
- AI and computational pathology can be practically applied to improve clinical trial outcomes.
- Regulatory aspects of digital pathology adoption in clinical trials are being actively addressed.

## 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, 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.

•A comprehensive review of digital pathology in clinical trials.•An outline of advantages to adopt digital pathology in clinical trials in today's data driven landscape.•Discussion of AI and computational pathology practical applications.•Addressing of regulatory aspects of digital pathology use in clinical trial setting.•Brief about future integrated approaches.

A comprehensive review of digital pathology in clinical trials.

An outline of advantages to adopt digital pathology in clinical trials in today's data driven landscape.

Discussion of AI and computational pathology practical applications.

Addressing of regulatory aspects of digital pathology use in clinical trial setting.

Brief about future integrated approaches.