For clinical research professionals, 2026 was not an abstract policy year. It was a year of real operational disruption, genuine scientific debate, and an uncomfortable truth: the regulatory environment is moving faster than the abilities of most organizations to adapt.

Five developments defined it. The U.S. Food and Drug Administration (FDA) ended the two-trial standard that had anchored drug development since the 1960s. The FDA's Real-Time Clinical Trials initiative moved from concept to proof of concept. National Institutes of Health funding disruptions terminated hundreds of trials, affecting tens of thousands of enrolled participants and causing lasting damage to academic research infrastructure. FDA workforce reductions created genuine review capacity constraints that are still affecting Investigational New Drug timelines and early protocol feedback. And the shift from mandated diversity action plans to voluntary reporting left organizations without clear guidance on what compliance actually requires now.

Attendees of this session will leave with a practical framework for operating confidently inside each of these changes and a clearer view of where the ambiguity still lives.

CEU: 1.0 ACRP

Speakers:

• Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare

• Sophia McLeod, Director, Government Relations, ACRO