The main areas of research by most contract research organizations in Italy include oncology and haemato-oncology (34.7%), rare diseases (30.6%), followed by diseases of the nervous system (11.1%), immune system (8.5%), cardiovascular system (6.2%), and blood and lymphatic system (6.1%).
All the clinical trials in Italy are regulated by the AIFA, the Italian Medicines Agency. The AIFA regulates and authorizes clinical trials through through the National Observatory on Clinical Trials (OsSC). All trials are performed according to European Union directives, with the information shared with the European EudraCT database.
The AIFA authorized 611 clinical trials after evaluating 764 trial requests in 2023. 2008 was the peak, with 880 clinical trials approved. In 2021, a high number of trials.
In Europe, France, Germany, Italy, and Spain have the largest number of clinical trial participation.
