# Geographic disparities in gastrointestinal oncology research: a focus on trial availability in Italy

## TL;DR

This study shows that gastrointestinal cancer clinical trials in Italy are unevenly distributed, with more trials in the North and fewer in the South and islands.

## Contribution

The paper highlights geographic disparities in clinical trial availability in Italy using a kernel smoothing analysis.

## Key findings

- Clinical trials are concentrated in Northern and Central Italy, with fewer in Southern regions and islands.
- Northern regions have 0.92 trials per 100,000 inhabitants, while islands have 0.53 trials per 100,000 inhabitants.
- The uneven distribution limits patient access and affects the representativeness of trial data.

## Abstract

Gastrointestinal cancers pose a significant global health burden, bearing as they do high incidence and mortality rates. Clinical trials in oncology offer numerous advantages as helping to develop new treatments and improve existing ones, leading to better patient outcomes, providing patients with access to cutting-edge therapies that might not otherwise be available and enhancing our understanding of cancer biology.

We retrospectively reviewed active interventional clinical trials in Italy in the field of gastrointestinal neoplasms in the period March 1, 2020 and March 1, 2024, by a search on the “clincaltrials.gov” database. The search yielded 103 studies active in Italy. For each study, the Centers in Italy at which they are active were extracted. Studies resulted active in a total of 630 locations.

The data analysis, by a kernel smoothing for probability density estimation, reveals a pronounced clustering of trials in Northern and Central Italy, while the Southern regions and islands exhibit lower trial availability, highlighting disparities in patient access. The mean number of clinical trials per 100 000 inhabitants was calculated. We found that Northern regions show a much higher concentration compared with the Southern regions and islands (North-east 0.92 CTs/100 000 inhabitants vs Islands 0.53 CTs/100 000 inhabitants).

The uneven distribution does not only limit treatment options for patients in less accessible areas but also raises concerns about the representativeness of trial data. This study underscores the need for targeted strategies to enhance trial accessibility, including decentralized trial models and national databases, to ensure equitable patient participation across Italy.