Abstract
BACKGROUND: Quantifying workload for clinical trial staff represents an ongoing challenge for healthcare facilities conducting cancer clinical trials. We developed and evaluated a staffing model designed to meet this need. METHODS: To address individual protocol acuity, the model's algorithms include metrics to account for visit frequency, and the quantity, and types of research-related procedures. Since implementation in 2012, the model has been used to justify clinical research team resource needs and to establish metrics for leadership to reference when reviewing replacement positions; particularly useful to justify resources at the institutional level during the COVID-19 pandemic.In recent years, we identified a gap between predicted and actual staff workload. This precipitated a comprehensive review in 2021 of all aspects of scoring within the model including a comparison to modern protocols to ensure accounting for all types of protocol-related procedures and tests. RESULTS: Further investigation identified increasing complexity of trial screening, which had not been accounted for in the initial model. Specifically, screening-related activities accounted for up to 25% of coordinator effort. We incorporated this work into the model and demonstrated a statistically significant change in average protocol acuity (P = 0.002) following refinement of scoring to include study-specific screening complexity. CONCLUSION: Over the past decade, cancer clinical trial screening has increased in complexity and duration. Planning a cancer center's clinical trial workforce requires consideration of screening-related staff effort. For any effort model to be successful, ongoing examination and malleability are critical in this evolving landscape of clinical trials.