AI Improves Endpoints and Evidence in Clinical Trials

The Big Unlock · Gregory Goldmacher, M.D., Associate Vice President in Clinical Research, and Head of Clinical Imaging & Pathology, Merck Research Laboratories

In this episode, Dr. Greg Goldmacher, Associate VP of Clinical Research at Merck, known as MSD outside of the United States and Canada, explains how AI is transforming imaging, clinical trials, and early-stage drug development. Greg describes endpoints as the core of every clinical trial, since they determine whether a therapy is safe or effective. He notes that AI is not new to imaging and aligns well with pattern recognition, yet its real value lies in identifying details that humans often miss.

Greg stresses that drug development still depends on huge volumes of data spread across legacy systems. Without strong data standardization, AI cannot deliver reliable results. He also points to the FDA’s evolving guidance on AI and emphasizes the need for rigorous validation before using AI-derived measurements for regulatory decisions.

Greg highlights the opportunity to improve efficiency, reduce human burden, and generate more consistent insights. With thoughtful adoption, AI can support better decisions in clinical development and improve outcomes for patients. Take a listen.