2024-03-21 11:15:40
(ANSA) – ROME, MARCH 19 – Faster times for the approval of clinical trials in Italy. This is the request that comes from a working group between the Italian Federation of healthcare and hospital companies (Fiaso) and Farmindustria which met today at the “G. Bonadonna” Auditorium of the IRCCS National Cancer Institute in Milan.
In 2022, clinical trials in Italy returned to 2019 levels, with 713 trials concentrated mainly in phases II and III, placing Italy third in the European Union for the number of clinical trials after Spain and Germany. Also in the same year, investments in research and development amounted to 1.9 billion euros, 6.8% of total investments in Italy.
Although the European Regulation for clinical research has established aligned authorization times for all member countries (from a minimum of 60 days to a maximum of 106 from the date of submission), in Italy the administrative approval processes are longer and difficult compared to the European average, the two organizations point out.
“Clinical research represents not only an opportunity for innovation, but is also crucial to improve the appropriateness of the care offered to patients and contribute to the sustainability of the system. Fully integrating clinical research into business strategies is essential to ensure efficient use of resources – underlines the president of Fiaso, Giovanni Migliore, in a note -. We therefore need to complete the regulatory framework soon to enable the clinical centers of the national health service to attract new investments and remain competitive also at an international level”.
“For our nation it is essential to ensure citizens have quicker access to innovation, with a more modern approach that we hope will come from the Aifa reform”, adds the president of Farmindustria Marcello Cattani.
“Because the times, added to those necessary for arrival in the individual Regions, are too long for patients, who have the right to be treated as soon as therapy is available”, he concludes. (HANDLE).
2024-03-21 11:15:40