The Italian Medicines Agency has published the 19th National Report on Clinical Trials concerning Medicinal Products in Italy, with data relating to 2019.

The Report provides a periodic update on the qualitative and quantitative trend of clinical research in Italy.

After a decline in 2017, the total number of clinical trials submitted in Italy in 2019 reached the historical levels already recorded in 2018, even in the context of a steady and general contraction in the number of trials conducted in Europe. This has led to a further increase in the percentage of trials authorised in Italy compared to the rest of Europe (22%).

One of the main differences compared to the previous year is the trend reversal of national trials that recorded a decrease compared to international trials, which instead increased in absolute terms, thus confirming that multicentre and multinational trials are the prevailing type in Italy.

The distribution of trials by therapeutic area confirms the data from previous years, with about half trials conducted in the field of oncology and haemato-oncology.

The upward trend of rare disease trials continued considerably, representing 32.1% of the total (31.5% in 2018), of which almost 82% are profit trials, mainly distributed among phases II and III. However, phase I rare disease trials accounted for 39 % of all phase I trials authorised in Italy in 2019.

A slight countertrend compared to the previous year was detected in the number of non-profit trials, representing 23.2% of the total number of trials conducted in Italy, compared with 27.3% in 2018.

On the other hand, paediatric trials were back at the levels registered in previous years, accounting for 9.1 % compared to 11.4 % in 2018.

The Report also contains data related to Italy’s participation in the Voluntary Harmonisation Procedure (VHP) project for the joint evaluation of clinical protocols conducted in several countries of the European Union.

Again in 2019, Italy was one of the main Member States handling VHPs, with 25 out of 115 trials and 128 substantive amendments managed as Reference Member State. A steady increase also emerged in the number of VHPs assessed in a coordinated manner with the respective Ethics Committee.

Finally, the Report is supplemented by a section with preliminary data on clinical trials concerning medicinal products for the treatment of COVID-19, limited to the period March-September.

The Report is available here:

Published on: 30 December 2020