Non-profit research: an insight into the management and monitoring of clinical trials in Italy

Introduction: In January 2022, Italy fully implemented EU Regulation No. 536/2014, revolutionizing the national framework for clinical research on medicinal products. This marked a critical shift for non-profit sponsors, who are now required to align with high-quality standards and ICH-GCP guidelines. Understanding their level of compliance is essential to identify systemic barriers and areas needing support. Methods: In March 2024, a 50-item anonymous pilot survey was distributed via social media to assess the operational and regulatory compliance of non-profit sponsors managing clinical trials in Italy. The survey focused on three domains: data management, risk assessment, and monitoring practices. Responses were collected from 32 non-profit sponsors. Results: The findings revealed substantial compliance gaps. Approximately 91% (n = 29) of respondents reported they rarely or never prepare core GCP-required documents, including Data Management Plans and Statistical Analysis Plans. Only 25% (n = 8) routinely conduct risk assessments before protocol drafting. Monitoring visits, either remote or on-site, were performed by 63% (n = 20) of sponsors. Among those not conducting on-site monitoring (n = 14), the primary constraints reported were staff shortages (29%, n = 4) and financial limitations (57%, n = 8). Alarmingly, within this same subgroup, 29% (n = 4) believed that on-site monitoring was unnecessary, despite regulatory mandates. This attitude extended to remote monitoring activities as well. Conclusions: The survey highlights major challenges faced by non-profit sponsors in meeting regulatory expectations. Limited resources and a lack of trained personnel significantly impair compliance with GCP standards. To ensure research integrity and patient safety, targeted support strategies and policy interventions are urgently needed to empower non-profit research in adapting to the evolving regulatory landscape.