Workforce Stratification as a Cancer Research Equity and Capacity Intervention: A Policy and Implementation Framework...

Equitable access to clinical trials is a recognised determinant of cancer outcomes, yet participation rates across oncology settings remain highly stratified by institutional research capacity. In Italy and across European health systems, a primary structural barrier to broader trial participation is the shortage of qualified clinical research personnel - a shortage sustained, in part, by an organisational model that conflates advanced data management competencies with routine data entry tasks, inflating the qualification threshold for trial activation at under-resourced sites. This article argues that a formal organisational distinction between a Data Entry Operator (DEO) and a Data Manager/CRC represents a cancer policy intervention: one that can expand trial access to under-resourced oncology sites, reduce the administrative burden on oncologists, improve data quality governance, and create a sustainable entry-level workforce pipeline in cancer clinical research. A tiered workforce model is proposed in which DEOs perform structured, protocol-driven data entry under DM supervision, while DMs/CRCs concentrate on regulatory compliance, adverse event management, protocol coordination, and quality assurance. DEOs would progress to full CRC qualification through concurrent work-based academic pathways. This model is compatible with ICH-GCP E6(R3) and EU CTR 536/2014 without legislative change. By lowering the staffing threshold for trial activation, the model may increase the number of oncology sites capable of conducting clinical trials, improve geographic and institutional equity in research participation, and strengthen the sustainability of the cancer research workforce. Implementation requires coordinated engagement from professional associations, academic institutions, and national cancer policy bodies. Prospective evaluation is required to confirm anticipated effects on site activation rates and trial access.