Abstract TMP40: Cost Analysis Of A Pooled Coordinator Model Versus Traditional Staffing For Acute Stroke Trials

Abstract

Introduction: Enrollment in acute stroke clinical trials (ASCTs) is complex and unpredictable. Traditional staffing models (TSMs) of research coordinator coverage assign a single research coordinator to cover specific clinical trials, whereas pooled staffing models (PSMs) utilize staff research coordinators to cross-cover multiple clinical trials, typically beyond traditional daytime hours. Methods: We calculated actual PSM costs accrued during one year (1/1/21-12/31/21) for two Phase III ASCTs (NCT03735979, NCT03785678). PSM costs were obtained from existing billing records for specific research coordinator tasks billed hourly ($78/hour) and a “retainer fee” ($690/month) for 24-7 on-call research coordinator coverage. Aspects of research coordinator work included: enrollment, data entry, query resolution, monitor visits, regulatory management, meetings, training/retraining, and patient visits. We compared PSM costs to the cost (salary + fringe) of a TSM full-time research nurse (1.0 full-time equivalent [FTE]) in the identical job class and salary as those employed in the PSM. Results: The estimated one-year cost (salary + fringe) of a 1.0 FTE RN research coordinator was $109,755.36. During the study period, there were 19 enrollments in NCT03735979; 9 occurred outside daytime working hours. The PSM cost was $60,813, equivalent to 0.55 FTE of coordinator coverage in a TSM with 90.0% more enrolled subjects. Additionally, there were 6 enrollments for NCT03785678; 4 outside daytime working hours. The PSM cost was $69,857.00, equivalent to the cost of 0.64 FTE of standardized research coordinator in a TSM with 200% more enrolled subjects. Conclusions: We demonstrated that a PSM for ASCT can be cost-effective for individual studies while increasing enrollment opportunities through 24-7 coordinator coverage. PSMs may offer a solution to the staffing and coverage challenges faced by many institutions seeking to participate in emergent clinical trials. Cost increases or savings with the PSM model would be dependent upon staff compensation, rates of enrollment, and reimbursement at individual sites.