Clinical research, Italy is fourth in the EU but few public resources for too many centres

Italy ranks fourth in the European Union for the number of clinical trials conducted since the beginning of 2022. In total, they amount to 2,674, while first place on the continent goes to Spain (with 3,500) followed by France (3,362) and Germany (2,831). Quite positive data, despite the fact that Italy is a nation that invests only 2.860 billion in biomedical research every year, compared to the 22 billion invested in general research and development (only 1.3% of GDP). In fact, we rank 18th among European countries and are also among the last in the world. Just 39% of these resources come from public funding while 1.3 billion come from pharmaceutical companies.

For years, our country has represented excellence in the field of medical and scientific research. However, there are several structural problems that need to be addressed as soon as possible. In addition to the chronic lack of funding, there is a severe shortage of specialised personnel in this particular sector, and thus we need data managers, research nurses, bioinformaticians, and researchers. The approval times for trials are still too long, and there is a need to speed up both the authorisation procedures and the approvals by the Ethics Committees.
All this is also reflected in a sharp decline in independent trials, i.e. those that are unrelated to the drug company. Finally, we have the absolute urgency of making all the benefits and innovations brought by clinical research available to patients as soon as possible.

In this regard, it should be noted that the overall time for patient access to new drugs is currently too long, even more than 500 days from Ema approval, even for the passage of regional therapeutic schedules. Priority must also be given to speeding up all the steps as much as possible, especially for innovative and orphan drugs, and also to eliminating regional therapeutic schedules, which would lead to zero access time at local level. Unfortunately, the composition of the new national ethics committee for clinical trials on advanced and highly innovative therapies will certainly not help Aifa. In fact, as far as bibliometric indices and the degree of relevance and appropriateness of specific professional and clinical-scientific experience are concerned, its current members show significantly lower values than the previous Committee.

Finally, medical research in Italy is also highly fragmented in terms of both funding and activities. A total of 54 Institutes for Hospitalization and Treatment of a Scientific Nature (Istituti di Ricvero e Cura a carattere Scientifico-Irccs) are active throughout the country, which the Ministry of Health has to supervise. There was a slight increase in public funding in 2024 to EUR 179 million compared to EUR 172 million in 2022. Last year, however, there was no increase in the number of trials conducted and patients involved, which stood at 7,421 and 61,887 respectively. Moreover, new healthcare facilities are applying for recognition as Irccs and are in the process of being recognised. There is a real risk of having more and more centres managing fewer financial and human resources. Minimum requirements must be laid down and accreditation procedures must be established and confirmed on the basis of these.

* President FOCE-ConFederation of Oncologists, Cardiologists and Haematologists