This pilot episode of The Human Side of Clinical Trials introduces a framework from Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., exploring why operational failures in clinical trials often trace back to gaps in human readiness rather than process design alone.
Clinical trials are built around protocols, processes, technology, and data. But their success ultimately depends on people being able to make good decisions and perform complex work under real-world conditions. In the first episode of The Human Side of Clinical Trials, Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., introduces the central idea behind the series: many challenges that appear to be operational problems may begin as human-readiness problems. When enrollment falls behind, protocol deviations increase, or sites struggle after activation, organizations often focus on what went wrong. McGowan argues that teams should also ask what happened earlier. Were people adequately prepared? Did training produce genuine understanding? Was the process easy to follow? Did staff have the right support when they needed to make a decision?
The episode introduces a practical framework based on learning science, cognitive science, and behavioral science. These disciplines help explain how people learn, remember, make decisions, respond to pressure, and interact with the systems around them. A central message of the episode is that knowing does not equal doing. Completing training or receiving information does not necessarily mean someone is ready to apply a protocol correctly. Throughout the series, Brian and his guests will explore how clinical research organizations can improve training, simplify workflows, reduce unnecessary friction, support sites more effectively, and identify risks before they become operational failures.
Listeners are invited to begin with one important question: Where are we assuming that people and teams are ready when we should be building, measuring, or supporting their readiness?
