Development and implementation of standardized study enrollment metrics for a VA healthcare system clinical research consortium: A 6-year follow-up assessment

Participant enrollment remains a leading indicator of the validity and generalizability of clinical trial results in the population at large. Establishing standardized and structured enrollment metrics can offer valuable information on clinical research performance (site and network level). The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) evaluated its performance against standardized study and network enrollment metrics over a 6-year timeframe from implementation of the metrics (VA Fiscal Year (FY) 2019) through FY 2024. Our findings demonstrate a positive trend in the ability of network sites to achieve NODES-specific enrollment metrics, comparing FY 2019 (55 %) to FY 2024 (73 %). Additionally, we identified improvement in study participant enrollment more broadly based on CSP study-specific enrollment metrics, as evidenced by an increase in the percentage that Node sites achieved ≥50 % of their expected enrollment targets in FY 2019 (64.7 %) on average compared to FY 2024 (69.5 %), and sustained performance as it relates to the percentage that network sites were in the "Top 1/3 of Study Sites Overall" comparing FY 2019 (36.9 %) to FY 2024 (36.1 %). Lastly, CSP Node sites enrolled study participants at a higher percentage than non-Node CSP study sites when comparing enrollment (actual/expected) by margins of 28.4 % (FY 2019) and 21.6 % (FY 2024), respectively. It is our hope that our experiences of navigating challenges associated with this effort, understanding lessons learned, and achieving successes might serve as a useful template for other clinical research consortiums that aim to evaluate their performance.