Adnkronos (Adnkronos) – L’Europa rallenta, la Cina accelera: tra il 2013 e il 2023 la quota europea sui nuovi studi clinici avviati nel mondo è scesa dal 18% al 9%, mentre quella cinese è salita dall’8% al 29% (Dati Efpia 2025). Per non restare indietro, la Lombardia punta sulle partnership, sulla trasformazione digitale e sulla competitività. Se ne è discusso ieri a Bergamo in occasione dell’appuntamento organizzato da Bion – Cluster lombardo scienze della vita, nell’ambito della nuova Academy sulla Ricerca clinica avviata nel 2026.
Il ‘Forum Ricerca Clinica’ è stato organizzato in collaborazione con Ieo (Istituto europeo di oncologia), Fondazione From e Asst Grande ospedale metropolitano Niguarda, con il supporto dell’Asst Papa Giovanni XXIII e Regione Lombardia, con il patrocinio e la collaborazione di Afi (Associazione farmaceutici industria), Frrb (Fondazione regionale per la ricerca biomedica), Fiaso, Gidm (Gruppo italiano data manager) e Simef (Società italiana di medicina farmaceutica).
Durante la giornata – informa una nota – si è discusso di politiche regionali, del ruolo dei Comitati etici territoriali, dei modelli di aggregazione come i Clinical trial center e delle azioni di istituzioni e centri di ricerca, della centralità del paziente e del suo coinvolgimento già nel disegno dello studio, di intelligenza artificiale e governance dei dati.
Tanti i temi, molte le prospettive condivise, ma un unico obiettivo: identificare le priorità per la competitività del Sistema lombardo, dai fondi della Ricerca alle politiche del Welfare di Regione Lombardia.
"The numbers tell us that clinical research is moving to other areas of the world, but the capacity to attract is also different in European countries, and unfortunately our country seems to be slowing down," explains Gianluca Vago, president of Bion. "With the Cluster, we have tried to discuss and explore the reasons that contribute to these delays, and to highlight possible interventions that can help us attract and preserve the value of non-profit research, which has slowed down at the national level. As has become clear thanks to the contributions of the various components involved in the authorization and operational processes, we believe that Lombardy can try to correct some of the dynamics that hinder and slow down participation in the most important clinical trials, focusing on monitoring, planning, and digital innovation. We need coherent regional policies, a streamlined bureaucracy that makes the analysis and approval phases by ethics committees faster and more reliable, a more favorable interpretation of the necessary regulations on the protection of personal data, and uniform standards within which to operate, in line with European Union guidelines. Furthermore, involvement that is not only formal but structural and "We are committed to developing a competent patient care system, starting from the study design definition phase. Furthermore, research we conducted this year highlighted the need to strengthen facilities with the most stable human resources possible, as well as the need to increase digitization rates for effective data use; data warehouses are still not widely used (approximately 37% of the sample interviewed). With this Forum, we wanted to offer an opportunity for in-depth analysis and discussion, aiming to make Lombardy a potential laboratory for scalable solutions for the entire country."
The study, conducted by Bion in collaboration with IQVIA and involving 19 regional centers, highlighted several priority directions for research. These include shared standards, a regional data warehouse to support research, and review and recognition of research staff roles, with priority given to training and secondary use of data.
"Clinical research in Italy today must contend with several structural issues," emphasizes Alessandro Rambaldi, scientific director of From, the Bergamo ETS Hospital Research Foundation. "The first is the lack of funding, the second is the excessive bureaucracy of the procedures for obtaining it, even at the European level. The need to control expenditure is understandable, but the consequence of this excessive bureaucracy is the marked lengthening of research times and the growth of its indirect costs, linked to administrative aspects. The third point concerns animal testing, which in Italy has become particularly difficult and extremely expensive. Finally, it is essential that large hospitals, like the Papa Giovanni XXIII in Bergamo, have the ability to draw from daily clinical experience the information and data useful for studying treatment outcomes. And this is, unfortunately, a wealth of knowledge that is increasingly difficult to use due to certain privacy regulations: the protection of patients' personal data, appropriately processed and anonymized, remains an essential principle, but it must not become an obstacle to scientific research that is born to improve care and quality." of the lives of the patients involved and beyond".
"Never before has the need to recognize clinical research as an integral part of the healthcare journey been so clearly demonstrated," adds Stefano Stabile, GCP Quality Assurance Manager, Asst Grande Ospedale Metropolitano Niguarda. "In this context, it is crucial to professionally and contractually value and recognize the professionals who carry out clinical research every day within hospitals and research centers: from Study Coordinators to research nurses. GIDM has been fighting for years to achieve this goal, recognizing the importance of promoting ongoing and constructive dialogue among all stakeholders involved and institutions. For this reason, events like today's represent valuable and important opportunities: moments of discussion, sharing, and dialogue, essential for continuing to build the future of clinical research together."
"We are convinced that developing a Clinical Trial Center model," concludes Giulia Peruzzotti, Director of the IEO Clinical Trial Center, "that can make clinical research more efficient, competitive, safe, and sustainable is a strategic lever for transforming scientific excellence into concrete opportunities for patients, through multidisciplinary expertise, technological innovation, and integrated care pathways."
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