AI Improves Endpoints and Evidence in Clinical Trials

December 17, 2025 00:31:50
AI Improves Endpoints and Evidence in Clinical Trials
The Big Unlock
AI Improves Endpoints and Evidence in Clinical Trials

Dec 17 2025 | 00:31:50

/

Show Notes

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.

Other Episodes

Episode 0

April 04, 2022 00:26:43
Episode Cover

Paula Turicchi: Digital health startups must ensure that they have a good business case based on reality

In this episode, Paula Turicchi, Chief Strategy Officer, Parkland Community Health Plan (PCHP), talks about how the organization went from a completely outsourced service...

Listen

Episode 0

May 31, 2022 00:24:42
Episode Cover

Tom Leary: By and large, public health IT infrastructure is glaringly 20th century.

In this episode, Tom Leary discusses the recently published report by HIMSS titled “Public Health Information and Technology Infrastructure Modernization Funding” which recommends over...

Listen

Episode 0

September 13, 2021 00:27:44
Episode Cover

Tony Ambrozie: A lot of digital adoption is driven by demographics

In this podcast, Tony Ambrozie, Chief Digital Officer of Baptist Health South Florida, shares his journey and learnings embracing digital in healthcare. Transformation in...

Listen