In recent years, non-profit clinical trials in Italy have drastically decreased (and globally it is not much better) reducing the diversity of research and opening up potentially distorted market scenarios

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.

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