From 2000 to 2022, over 15,400 clinical trials were launched in Italy, with a peak of 818 in 2021 also thanks to the many trials on Sars-Cov-2. From vaccines and monoclonals to anti-inflammatories, during the Covid-19 pandemic, research efforts focused on Sars-CoV-2 and 107 clinical trials were started in 3 years. This is indicated by the twentieth ‘Report on clinical trials of medicinal products in Italy 2023’, published by the Italian Medicines Agency (Aifa). Clinical studies, i.e. carried out on humans, have the objective of testing the efficacy and safety of new therapies, also by comparing them with those already available, to improve the possibility of healing and the quality of life of patients.
Being able to participate is often an opportunity to access innovative therapies, such as gene therapies. The Aifa report highlights how trials increasingly involve both men and women and are multi-centre, i.e. involving multiple research centres, universities and often international hospitals, an aspect that qualifies their level.
The number of studies authorized in 2020, i.e. 683, was the highest in the previous 7 years and the figure is significant if we consider the negative impact of the pandemic on the management of trials in many areas, which should have led to a contraction of those start: contraction partly compensated by the studies on Covid, which were around 10% of those started.
It follows a peak of 818 authorized studies in 2021, the year in which the trials scheduled in 2020 but which had been blocked due to the pandemic recovered. “The figure is even more significant, because it marks a return in the volume of research to levels not seen in Italy for over 10 years”, explains Aifa. In 2022, the trials started drop to 663, a number that indicates the return to an average level of the studies authorized in the previous decade but which could also be influenced by the full application of the Community Regulation on the subject and of the evaluation system for clinical trials in Europe .
As for lenders, in the three-year period 2020-22 the share of trials promoted by pharmaceutical companies is growing and the number of non-profit ones is decreasing. Among the latter, the number of trials stands out Gemelli Polyclinic Foundation Irccs-Catholic University of the Sacred Heart and the San Raffaele Hospital in Milan.
The area of tumors is confirmed as the one with the most authorized trials, around 40% of the total. Trials on drugs for rare diseases have seen a reduction due to the problems caused by the pandemic and a subsequent recovery of the lost ground: they were 194 in 2020 (28% of the total) and 230 in 2022 (38%).
Starting from the first trial, that of March 2020 on the antiviral remdesivir, there were 107 authorized studies on Sars-Cov-2 in the three-year period under review: they concerned many therapies, of chemical or biological origin, including the most discussed ones, such as plasma, hydroxychloroquine and vitamin D.
In the case of Covid, 95% of the studies were promoted by public bodies, among which it stands out in first place the Lazzaro Spallanzani Institute of Infectious Diseases in Roma, with 6 trials started, followed by the Modena University Hospital, with 5.
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