Here's why clinical research will decide the future of European medicine

On 20 and 21 May 2026 the Policlinico Universitario Agostino Gemelli IRCCS will host Clinical Trials Day, a two-day event dedicated to the future of clinical research, therapeutic innovation and data-driven medicine. It will not only be a scientific congress. Above all, it will be a moment of strategic reflection on what is happening to contemporary medicine: a radical transformation that simultaneously involves drugs, devices, artificial intelligence, healthcare organisation, regulation, economics and the geopolitics of health.

For many years, clinical trials were perceived as an activity confined to large academic centres, important but essentially parallel to everyday care. Today, this paradigm is definitely outdated. Clinical trials are becoming the very heart of access to innovation. In the coming years, for many patients, especially cancer, neurological and rare or complex chronic disease patients, entering a trial will often mean first - and sometimes only - access to the most advanced treatments available in the world. This is a historic change. Medicine is in fact experiencing one of the greatest accelerations in its history. Increasingly sophisticated therapies are emerging in oncology, neuroscience, immunology, cardiovascular medicine and gastroenterology: drug-conjugated antibodies, radioligands, engineered cells, gene therapies, RNA therapeutics, next-generation immunotherapies, smart devices, digital therapeutics, predictive algorithms, advanced robotics, continuous monitoring systems and integrated personalised medicine platforms. This revolution is changing the very concept of treatment. We no longer look only at the diseased organ but at the molecular, immunological, metabolic and digital profile of the patient. New technologies make it possible to identify extremely specific biological subgroups and to build customised treatments.

But the more sophisticated medicine becomes, the greater the need for advanced clinical research. Innovations must be validated quickly, but also in a rigorous, safe and transparent manner. They must be tested in international networks, on large, well-characterised populations, with efficient regulatory systems and with infrastructures capable of guaranteeing methodological quality and compliance with Good Clinical Practice. In this scenario, the role of IRCCSs becomes central. IRCCSs represent an Italian peculiarity of enormous strategic value: facilities in which research, care and training coexist on a daily basis. This integration is fundamental because it allows innovations to be transferred rapidly from the laboratory to the patient's bedside. It is no coincidence that many of Italy's most important clinical trials originate within the IRCCS network. However, today this network must make a further quality leap. No centre alone can cope with the complexity of contemporary medicine. New trials require large numbers, multidisciplinary expertise, biobanks, genomic platforms, data science, bioinformatics, advanced imaging, regulatory expertise, statistical support, digital monitoring and international management capabilities. This is why collaboration between IRCCSs, universities, research centres and European networks is no longer optional: it is a national strategic necessity. Indeed, global scientific competition will increasingly be played out on the ability to build collaborative ecosystems. The United States has developed highly integrated models between universities, the biotech industry, venture capital and large hospitals. China is investing heavily in translational research platforms and artificial intelligence applied to health. Europe, on the other hand, risks progressive marginalisation if it fails to speed up decision-making processes, simplify procedures and strengthen its scientific networks.

One of the topics that will be discussed during the Clinical Trials Day is precisely the new geopolitics of medicine. Recent US policies inspired by the logic of the Most Favoured Nation Clause are redefining the balance of global access to innovative drugs. The real risk is that pharmaceutical companies will increasingly favour the US market in their initial distribution strategies, slowing down the arrival of innovations in Europe. This could have enormous consequences. Highly innovative therapies could become available in the US years in advance of European healthcare systems. In this context, participation in clinical trials could become, for many European patients, the main tool for early therapeutic access. This is a profound transformation that calls for political and organisational reflection.

If we want Italia to remain competitive, we have to be faster. Speed today does not mean superficiality. It means organisational capacity, regulatory quality, digitisation of processes, data interoperability, ethical and administrative speed, specialist skills and dedicated infrastructure. Modern clinical research cannot be sustained by the talent of individual researchers alone. It requires true organisational platforms. For this reason, Clinical Trial Offices, data managers, study coordinators, biostatisticians, monitors, regulatory experts, pharmacovigilance specialists, quality experts and all those professions that are often invisible but indispensable for conducting clinical trials in compliance with international GCP are taking on a decisive role.