The Report on the clinical trials of medicinal products in Italy 2023 illustrates the data of the clinical trials presented in our country in the three-year period 2020-2022.

The period considered includes the entire course of the COVID-19 pandemic emergency, in which research efforts, starting from March 2020, focused on testing treatments against the SARS-CoV-2 virus. It also coincides with the gradual implementation of Regulation (EU) 536/2014 (with the launch of the Clinical Trial Information System (CTIS) on 31 January 2022), which has changed the paradigm of clinical trials in Europe.

The partial temporal concurrence of the two events significantly conditioned the progress of clinical trials also in Italy. The level of studies authorised in 2020 and 2022 (683 and 663 respectively) was substantially in line with the average value recorded in the previous decade; in the middle, however, we observe the peak of 818 studies authorised in 2021, the year in which the trials planned in 2020 but not started due to the pandemic were partially recovered.

The value recorded in 2020, already slightly up on the previous year, was the highest in the previous 7 years; the figure, which includes about 10% of studies on SARS-CoV-2 (61), is particularly significant precisely if we consider the negative impact of the pandemic on the general management of clinical trials in other areas, which in theory should have led to a decrease in trial applications.

The 2021 data is even more significant, because it marks a return of the volume of research to levels not seen for over 10 years. Finally, 2022 marks a return to the average level of studies authorised and initiated in the previous decade, while the management model of the European CTIS portal has gradually settled down.

The 2023 Report provides data relating to the progress of clinical trials in Italy and the conclusive data of the studies presented in our country as part of the Voluntary Harmonisation Procedure (VHP), the European project for the harmonised evaluation of clinical protocols taking place in several EU Member States and launched in preparation of the Regulation.
A section of the Report is dedicated to clinical trials and therapeutic use programmes for COVID-19.