Adoption of Artificial Intelligence-Based End Points - A New Era for Clinical Trials

AbstractEnd point evaluation is central to the evidence generation process in a clinical trial, and artificial intelligence (AI) tools have the potential to improve the efficiency and accuracy of this process. In 2025, the European Medicines Agency and U.S. Food and Drug Administration independently endorsed AIM-NASH, an AI-based tool for histologic assessment in clinical trials for metabolic dysfunction-associated steatohepatitis. As the first ever regulatory certification of an AI-enabled end point, this represents a milestone for the emerging development and use of AI tools for drug development. This article examines the evidence and policy decisions underlying the endorsement and explores the clinical and regulatory implications of AI-enabled end points for the transformation of clinical trials.