Clinical research, more public funding needed

As often happens in Italy, although research funding is scarce, the results obtained are very respectable. And of course it is easy to think that if funding and personnel were greater and the organization better, the advantages for patients would be huge.

In Europe, Italy is fourth in terms of the number of clinical trials conducted from the beginning of 2022 to date, after Spain, France and Germany. An overall positive figure, although Italy is a nation that invests only 2,860 billion in biomedical research each year compared to the 22 billion invested overall in general research and development (only 1.3% of GDP). Just 39% of the total of these resources comes from public funding while 1.3 billion comes from pharmaceutical companies, especially for clinical trials.

“Our country has been an excellence in the field of medical-scientific research for years – says Francesco Cognetti , President of the Confederation of Oncologists, Cardiologists and Hematologists (Foce) -. However, there are several structural problems that need to be addressed as soon as possible”.

Not just funding

In addition to the chronic lack of funding, specialists also complain about a severe lack of specialized personnel: data managers, research nurses, bioinformaticians, researchers. Approval times for trials are still too long and it is necessary to speed up both the authorization procedures and the approvals by Ethics Committees. "All this is also reflected in a sharp decline in independent trials, that is, those not tied to the drug company.

Emblematic in this sense is the case of oncology, where now only 20% of studies on new molecules against cancer are non-profit while the remaining 80% are sponsored. Finally, we have the absolute urgency to make all the advantages and innovations brought by clinical research available to patients as soon as possible" continues Cognetti. "In this regard, it should be noted that the overall times for patient access to new drugs are currently too long, even more than 500 days from EMA approval also for the passage of regional therapeutic formularies. A priority must also be to speed up all the steps as much as possible especially for innovative and orphan drugs and also to eliminate regional therapeutics and this would lead to a zeroing of access times at local level which represent a real violation of article 32 of the Constitution. Unfortunately, the composition of the new National Ethics Committee for clinical trials relating to advanced and highly innovative therapies (gene and cellular therapies, tissue engineering products and combined advanced therapy medicines) will certainly not help Aifa. In fact, with regard to the bibliometric indices and the degree of relevance and appropriateness of the specific professional and clinical-scientific experience, its current members show significantly lower values ​​than the previous Committee”.

Optimize resources

"More than ever, in times of economic crisis, we need to optimize resources, avoid waste and ensure that clinical research immediately responds to the real needs of knowledge and health of millions of patients - underlines Giuseppe Ippolito , Professor at the International Medical University in Rome -. In other words, we need to reduce the amount of duplicative research, or that produces unusable results. In a context of limited resources, duplication of funding to the same subjects by public institutions must be avoided. Greater coordination is also needed since often different organizations, both public and private, are not aware of each other's projects, networks and program agreements.

“Biomedical research in Italy produces a high number of publications, including good quality ones, but Italian translational research unfortunately attracts little funding in terms of venture capital – adds Sergio Abrignani , Full Professor of General Pathology at the University of Milan -. Italian pharmaceutical companies carry out a large production and export of old-generation chemically extracted drugs and very little research and innovation, with due exceptions, on biological products for precision medicine (monoclonal antibodies, recombinant proteins, messenger RNA drugs). Furthermore, our most important problem is that of technology transfer from research to preclinical development, and subsequently to early-phase clinical research. In this regard, a greater role, as is the case in other European countries, could be played by greater promotion of this sector by philanthropy. In oncology, also in Italy, public-private collaboration in recent years has led to the development of new innovative treatments such as, for example, immunotherapy, which has radically changed clinical practice in some neoplasms”.

Too fragmented research

"Medical research in Italy is extremely fragmented both in terms of funding and activity - continues Cognetti -. This makes it even more difficult to carry out or complete experiments or studies that are often of an excellent level. There are a total of 54 Scientific Institutes for Hospitalization and Treatment - IRCCS active throughout the country, which the Ministry of Health must monitor. There was a slight increase in public funding in 2024, which rose to 179 million euros compared to 172 in 2022. Last year, however, we did not register an increase in the trials conducted and patients involved, which stood at 7,421 and 61,887 respectively. Furthermore, new healthcare facilities require recognition as IRCCS and are in the process of being recognized. There is a real risk of having more and more centers managing fewer financial and human resources. Minimum requirements must be established and accreditation procedures must be established and confirmed on the basis of these. Many IRCCS conduct very few or no clinical studies. The quality of their scientific activity, in accordance with internationally recognized bibliometric parameters, is absolutely insufficient in about half of them. It is absolutely not possible to continue to increase the number of IRCCS with new recognitions while leaving the overall funding practically unchanged and therefore without divesting the less productive IRCCS. A system of this kind inevitably damages the most productive IRCCS, whose scientific performance, in fact, has been significantly decreasing in recent years. It is a real shame because our researchers have contributed with their studies to the progress of research, especially in the field of clinical oncology where changes have been made to the guidelines and recommendations used in all countries”.

“Alongside the IRCCS, public research institutions (EPR) make an important contribution to Italian biomedical research, especially in the field of translational and preclinical research, both in terms of scientific publications and technology transfer – says Luisa Minghetti , Director of Coordination and Promotion of Research at the Istituto Superiore di Sanità -. Greater integration of EPRs into the biomedical research system and the availability of national platforms can give a new impetus to research, helping to overcome the fragmentation of our research system and promoting technological innovation. From this perspective, the Istituto Superiore di Sanità, the only EPR supervised by the Ministry of Health, can play an important role”.

Research serves patients

“Research must provide patients with all possible advantages in terms of survival and quality of life,” continues Rosanna D’Antona, President of Europa Donna Italia. “This does not always happen in Italy, especially not uniformly across the entire national territory. Innovative drugs are not always immediately available in all 21 health systems, also due to regional formularies. We find ourselves, especially for life-saving drugs, faced with strong inequalities in access, as we have been reiterating for years in our “TSM Manifesto,” where at point 3 we ask that drug approval processes be accelerated, so that they can be prescribed more quickly to guarantee all patients the same opportunities.”

Italian excellence

“The level of excellence of Italian oncology is also demonstrated by the five-year survival rate for all forms of cancer,” Cognetti continues. “It currently stands at 59% for men and 65% for women, but how long can these significant advances last in the absence of concrete interventions? Research in oncology is focusing on the use of innovative therapies and molecular tests. Greater knowledge of DNA allows us to better approach the diagnosis and treatment of many tumor diseases.” “As in oncology, in hematology too we are increasingly moving in the direction of precision medicine,” Paolo Corradini , Past President of the Italian Society of Hematology-Sie. “Treatments are more personalized and focused on the individual case of blood cancer, and more generally their effectiveness has improved significantly over the last few years. Diagnosis and therapies have undergone great innovation and allow us to cure the patient in the majority of cases. All this has also been possible thanks to ongoing clinical research, which must however continue to find new and even more targeted treatments.”

Research saves lives

“Cardio, cerebro and vascular diseases still represent the number one cause of death in Italy today – says Ciro Indolfi , President of the Italian Federation of Cardiology – with important differences between the North and the South. From an economic point of view alone, in our country direct costs are estimated at 42 billion euros per year for cardiovascular diseases, to which indirect costs must be added, as well as obviously the suffering and difficulties for patients and caregivers. Although coronary angioplasty has significantly reduced death from heart attacks, ischemic heart disease in men and women is the main cause of death since 50% of these patients die prematurely from sudden death before being able to be hospitalized. It is therefore necessary to strengthen research in the field of cardiovascular diseases which today, also thanks to artificial intelligence and new drugs available, could bring Italy to a low cardiovascular risk like the neighboring countries of France and Spain”.