Gastrentrological Clinical Trials in Italy: An Association study on regional Economic Factors and Healthcare System Efficiency

Maurizio Gaetano Polignano^*Davide GuidoIRCCS National Institute Of Gastroenterology S. De Bellis Research HospitalGianluigi Giannelli

• National Institute of Gastroenterology S. de Bellis Research Hospital (IRCCS), Bari, Italy

This study investigates the geographical distribution of gastrointestinal oncology clinical trials (CTs) in Italy and their association with regional economic factors and healthcare system efficiency. Despite the Italian National Health Service (NHS) providing universal healthcare, significant disparities exist, particularly between wealthier northern/central regions and less affluent southern regions. The study examines how socio-economic parameters, NHS funding, and specialized research institutions (Institutes of Hospitalisation and Care of a Scientific Character, IRCCS) influence CT accessibility and distribution. A retrospective analysis of 103 active interventional CTs (March 2020-March 2024) registered on ClinicalTrials.gov was conducted. Socio-economic and healthcare data, including population density, NHS expenditure, regional income, and unemployment rates, were sourced from national databases. Spearman's association and Poisson regression analyses evaluated associations between CT numbers and regional variables for Italy's 20 regions. CT distribution was highly clustered, with 44% conducted at IRCCS facilities, predominantly in northern/central regions. Strong associations were observed between CT numbers and NHS expenditure (ρ=0.913, p<=0.001) and population density (ρ=0.777, p<0.001). Southern regions and islands hosted fewer trials, reflecting lower healthcare funding and IRCCS availability. Also, total number of IRCCS facilities (both public and private) shows a strong positive correlation with the number of CTs (ρ = 0.837, p < 0.001). Regression models identified population size, density, and health expenditure as significant predictors of CT numbers, while unemployment showed an inverse relationship. No association was found with public pharmaceutical expenditure. Regional disparities in CT accessibility are driven by economic inequality and uneven healthcare infrastructure. Targeted policies to increase funding, expand IRCCS networks in southern Italy, and promote equitable resource allocation are urgently needed. CT distribution may serve as a novel indicator of healthcare system performance. Addressing these imbalances is vital to ensuring equitable patient access to innovative therapies and optimizing the NHS's research capacity nationwide.