So Lombardy can become a European hub for drug research

Turning Lombardy into the 'European capital of clinical research' by intervening on the bureaucracy and red tape that hold back trials on new drugs, given that potentially the region that already attracts 43% of clinical trails has everything it needs to become a hub: from a network of facilities of excellence - 20 Irccs and a hospital network among the most advanced in Europe - to a unique scientific and industrial ecosystem and growing investments. "But the numbers tell us that this is not enough," explains Nicoletta Luppi, vice-president of Assolombarda with responsibility for Europe and Life Sciences, because in the three-year period 2022-2025, Italia has enrolled around 25 thousand patients in multinational trials, with the activation of 1,100 clinical trials, 450 less than Spain and 250 less than France and Germany. "When Spanish centres start enrolling the first patients, we are still struggling with administrative procedures: an average enrolment window longer than 35 days results in an estimated loss of 2.5 patients per day per study. It is not a question of scientific quality, it is a question of governance,' Luppi adds. Hence the RAIL (Research Act and Innovation in Lombardy) project - whose first findings will be presented tomorrow on the International Clinical Trials Day - involving public and private players led by Assolombarda, which has identified four priority lines of action that can help Lombardy make this further leap forward in clinical research. These are: first of all, starting up the contractual system in parallel with the authorisation process; extending and clarifying the applicability of standard contractual templates; making reference price lists transparent and shareable, with each centre making its own reference price list for clinical research costs structured and accessible, reducing heterogeneity and making negotiations faster and more predictable; and finally, investing in the training of dedicated professional figures - especially data and study managers to be trained on artificial intelligence - which are currently lacking and whose deficit slows down processes by several months. "Lombardy can and must become the European benchmark. We owe it to the patients who are waiting for the cures of the future, to our healthcare system, which must be able to offer the best innovative therapies, and to the companies that want to invest in a reliable and predictable system,' concludes the Assolombarda vice-president with responsibility for Europe and Life Sciences .

Today, the clinical trials industry generates 21.7 billion euros of gross added value each year in the European Economic Area and supports a total of around 165,000 jobs, of which more than 45,000 are directly employed in clinical research. In Italia, annual investments in clinical research are estimated at around EUR 750 million, with an extraordinary multiplier: every euro invested generates EUR 2.77 of return for the National Health Service. Yet, Europe is losing ground: between 2013 and 2023, Europe's share of global industrial trials has practically plummeted from 22% to 12%, and Italia is no exception, despite starting from a recognised foundation of excellence.