Drug research, how Italia is still losing ground in Europe

The race for research into new drugs, where competition is becoming increasingly fierce, between the pressure of the USA and the rise of China, is seeing Europe an+end too slowly and Italia losing ground even compared to other European countries. Clinical research made in Italy, since the new European rules that have redesigned trials to make them more efficient were triggered four years ago, is in fact not as attractive as it could be, yet the investments led by pharmaceutical companies mobilise up to 700-800 million a year and enrol thousands of patients who can access new therapies, even life-saving ones, with benefits for the entire National Health Service.

The latest data coming from the new European digital platform on clinical trials in the Old Continent (the Clinical Trials Information System) and collected by Altems - the Alta Scuola di Economia e Management dei Sistemi Sanitari of the Università Cattolica del Sacro Cuore - show how between February 2022 and June 2025 our country ranks fourth in Europe, increasingly distant from Spain, which is becoming a pole of attraction for trials, and behind Germany and France as well. The data - which will be published in the next few days in the 'missed opportunities' report produced by involving 7 pharmaceutical companies - say that in this period, Italia has activated almost 1100 multinational clinical trials (this is a representative, albeit not complete, sample), a good 450 less than Spain and about 250 less than France and Germany. In oncology - which accounts for about a third of the studies - Italia ranks third in Europe, while in the other therapeutic areas its attractiveness is lower, even compared to countries such as Poland, the Netherlands and Belgium. What is important, however, is that in the three-year period about 25 thousand patients were enrolled - based on the 1100 studies - to test the new drugs, but if Italia had performed like Spain it would have enrolled at least 10 thousand more. But why these less brilliant performances? As is often the case for Italia, it is bureaucracy that weighs heavily: for example, the Altems data show that we have a delay of 8 days compared to the European average until the first patient is enrolled. The delay is more evident with Spain: when Spanish centres start enrolling, in Italia we are often still in the phase of completing administrative activities with an average 35-day shorter enrolment window, which translates into an estimated loss of about 2.5 patients per day per study. A further critical element concerns the strategic positioning vis-à-vis sponsors: in Italia, lower enrolment targets are assigned, and so if Italy finds itself with an average of 16.22 patients per study, compared to 38.11 in Spain.

"Each patient not enrolled is not just a negative statistical indicator: it means an innovative treatment not intercepted, entirely supported economically by the sponsor, and therefore an investment that does not enter the NHS circuit. It means clinical, economic and professional resources that are absorbed by other countries," warns Emmanouil Tsiasiotis, director of the Msc Altems laboratory and coordinator of the project, which follows in the wake of Altems' experience on the subject of so-called averted costs when it was shown "how clinical research is also a lever of sustainability for the SSN" because every euro invested directly by pharmaceutical companies produces three to the benefit of the SSN. In the three-year period 2017-2020, 623 million were calculated, which means that if Italia had enrolled in the last three years at the rate of Spain, we would now have obtained at least 180 million more indirect investments. This is why Altems aims to make this tool available to institutions and industries to better govern clinical research, a bit like Spain did with the 'Proyecto Best' that made it more competitive. "Thanks to this monitoring that we make available to the Ministry of Health and industries, we have clarity that our level of competitiveness in clinical trials is low compared to other countries similar to us, such as Spain, but we have also understood what there is room for recovery, which concerns both the activation phase of studies and the need to give more visibility to the quality of our centres. For example, I believe that among the indicators for evaluating the IRCCSs, we should also add that of the capacity to attract clinical research,' emphasises Americo Cicchetti professor of Business Organisation at the Faculty of Economics at the Cattolica University.