Clinical trials are often described as complex, but complexity alone does not explain why some studies struggle more than others. Some trials are operationally fragile: small disruptions in staffing, scheduling, participant availability, caregiver involvement, vendor performance, budget assumptions, endpoint execution, or communication pathways can quickly lead to enrollment delays, protocol deviations, site fatigue, participant dropout, budget disputes, and data quality concerns.

This session will introduce an Operational Fragility Framework for identifying clinical trial risk before enrollment begins.

Attendees will learn how to apply the framework for recognizing when trial fragility emerges during feasibility, site selection, budget review, study start-up, and operational planning and then, using real-world clinical operations examples, how to distinguish between trials that are merely complex and trials that require enhanced operational mitigation.

CEU: 1.0 ACRP

Speaker:

• Tia Warrick, Chief Executive Officer, Lesous Consulting LLC