Authors:
Celeste Cagnazzo, Silvia Stacchiotti, and Giuseppe Procopio View all authors and affiliations
Abstract
The 22nd National Report on Clinical Trials of Medicinal Products published by the Italian Medicines Agency (AIFA) in July 2026 highlights contrasting trends in Italian clinical research. In 2024, 669 prospective clinical trials were authorized, the highest number recorded in the last three years. Oncology and hemato-oncology remained the leading therapeutic area, accounting for 248 (37%) authorized trials and showing the largest absolute increase compared with 2023. Despite a stable overall number of authorized clinical trials, the composition of Italian clinical research is changing, with a progressive shift towards industry-sponsored and international studies and a decline in the relative contribution of non-commercial investigator-initiated trials (IITs). This decline is particularly relevant to oncology, a field historically supported by academic cooperative groups and independent research networks, especially in rare cancers and areas where IIT research has traditionally complemented commercially sponsored drug development. Several factors, including increasing regulatory, administrative, technological and organizational complexity, may contribute to the observed decline by disproportionately affecting academic sponsors. Strengthening Clinical Trial Units and investing in dedicated research professionals should therefore become a strategic priority. The future competitiveness of Italian oncology research should be measured not only by its ability to attract industry-sponsored trials, but also by its capacity to generate independent research addressing unmet clinical questions and needs.