[Non-profit clinical research in Italy: opportunities and unresolved challenges.]

Clinical research is a fundamental component of scientific progress and drug development, traditionally divided into profit-driven studies promoted by industry and non-profit studies conducted by public bodies or independent institutions with the aim of improving clinical practice. In Italy, non-profit research was long governed by a restrictive regulatory framework (Ministerial Decree of 17 December 2004), which significantly limited the possibility of exploiting research results for regulatory or commercial purposes, thereby hindering the development and impact of the evidence generated. The new Ministerial Decree of 30 November 2021 introduces a major shift by allowing the transfer of data and results from non-profit studies for regulatory purposes, fostering greater integration between the public sector and industry. However, the practical implementation of this reform presents several challenges, including the lack of clear criteria for the economic valuation of data, uncertainties regarding reimbursable costs, complexities related to data protection and informed consent, and a significant administrative burden on non-profit sponsors. Additional issues concern data quality, the operational sustainability of the system, and restrictions on co-sponsorship, which may reduce the international competitiveness of Italian research. In conclusion, while the new regulatory framework represents a step forward in enhancing the value of independent research, further regulatory clarification and structural interventions are needed to ensure its effective implementation and to fully realize its potential.