According to the 20th National Report on Clinical Trials of Medicinal Products in Italy, published by the Italian Medicines Agency (Aifa), a total of 5,217 clinical trials were conducted in Italy in 2023: 30% were phase I studies, 25% phase II, 35% phase III and 10% phase IV.
The leading area was oncology, for which 40% of Italian studies were developed, although, according to the Italian Association of Medical Oncology (Aiom), academic and non-profit trials in the field of oncology have fallen sharply.
Collapse of non-profit studies
The reduction in the number of non-profit studies, compared to the decade 2009-2019, is in the order of about 50% (from 309 to 156 studies) and has been confirmed in the last three years, up to the most worrying figure of 2022, which was the year with the lowest number of non-profit studies since 2000 (only 98 studies).
It is well known that Italy invests a relatively low percentage of its GDP in research and development, just 1.5%, compared to the EU average of 2.1%. Of this figure, only 10% is allocated to the health sector: 10% of the investment is non-profit, while the remaining 90% comes from private sources, amounting to €750 million per year.
Constraints on independent clinical research
Fadoi’s ‘Manifesto’ of 2023 emphasises that the decline of independent clinical trials is a serious and tangible problem in the clinical research landscape in Italy. The current trend sees a predominance of studies promoted by industrial entities at the expense of non-profit ones.
This shift towards company-led research, although legitimate, can lead to a distorted view of the benefits of pharmaceutical products. Independent clinical research in Italy is constrained by several factors that hinder its development and effectiveness.
Among the main critical issues are the scarcity of financial and human resources, together with excessive bureaucracy that slows down processes and undermines efficiency.
A few solutions
The Manifesto proposes several solutions to overcome these obstacles and promote more efficient and transparent clinical research. One of the central proposals is the creation of a national research agency, linked to the presidency of the council, with the task of coordinating research activities, promoting collaborative networks and simplifying regulatory procedures. A single text of clinical regulation is also proposed to simplify the current regulatory framework.
As far as privacy regulations are concerned, European intervention is called for to harmonise the rules and encourage the conduct of observational research. It is crucial to reform university curricula and healthcare collective agreements to introduce professionals needed for clinical research.
Training plays a crucial role, with proposals to integrate curricula and offer post-graduate training courses dedicated to clinical research.
Finally, the Manifesto calls for greater availability of public funding to support research in an ongoing and effective manner.
The situation at global level
A similar trend can be seen globally, especially in the field of cell and gene therapies where industry-sponsored trials have almost tripled while those supported by non-profit organisations have grown by only 5%.
The Atmp sector has seen a significant increase in clinical trials over the last decade, but the imbalance between industry-sponsored and non-industry-sponsored research is significant.
In 2023, 631 clinical trials for cell and gene therapies were initiated. Of these, 36% were non-industry trials, while the remaining 64% were industry-sponsored, with or without the involvement of non-industry entities.
While the number of non-industry trials has remained relatively stable over the past decade, industry-sponsored trials have increased by 276% since 2013 and by 34% compared to five years ago.
CAR-Ts dominate
One of the main factors behind this growth is research into CAR T-cell therapies. In 2013, only four industry-sponsored trials for CAR T-cell therapies had been initiated, but this number has risen to over 150 in the last three years. However, in 2023, the share of CAR T trials dropped to 39% from a peak of 44% in 2022, in favour of a growth in trials for gene therapies.
Different areas of interest
Industrial and non-industrial trials focus on different types of cell and gene therapies. Both sponsor categories showed increasing interest in CAR T therapies, with 39% of industrial and 38% of non-industrial trials started in 2023. However, the most marked difference is observed in gene therapies: in 2023, industry initiated 88 trials for gene therapies (22%) compared to only 26 (12%) for non-industrial.
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