Tracking a decade of phase I clinical trials in Italy: trends and insights from national and european registries amid regulatory change

While Phase I trial activity in Italy remained stable over the past decade, structural imbalances persist-including limited non-commercial engagement, strong therapeutic concentration in oncology, and underuse of healthy volunteer models. Strengthening infrastructure for early development, supporting academic-led studies, and promoting broader inclusion in study populations may help consolidate recent progress and foster a more balanced national research ecosystem.