This session explores the transformative role of real-world data (RWD) in modernizing and optimizing clinical trial design. Using a case-study based approach, attendees will learn how RWD can be applied to three high-impact areas. The first is modeling inclusion/exclusion criteria and patient attrition to simulate how changes in criteria impact the addressable patient pool and primary endpoints. The second is control arm validation and benchmarking to ensure comparator arms reflect relevant standard of care and that the trial is appropriately powered to show a statistically significant benefit. The third is evidence-based accrual metrics to facilitate site selection and build more accurate, reliable enrollment projections. Attendees will gain essential tools to transition from traditional protocol design to efficient, data-informed methodologies that ultimately accelerate study start-up, minimize protocol amendments, and significantly enhance trial accrual.

CEU: 1.0 ACRP

Speakers:

• Chelsea Osterman, MD, Executive Medical Director, Tempus AI

• Emilie Scherrer, Sr Director & Head of Outcomes Research, Tempus AI