Clinical trials are a type of study carried out to gather data on the safety and effectiveness of new therapies or of new medical devices.
Such trials may be carried out only once all the necessary information concerning the characteristics of the therapy/procedure and its safety have been gathered.
In order to proceed with clinical trials approval of the ethical committee is required.
Only patients who sign the specific informed consent form may be recruited.
For further details you may consult the website of the Italian Drug Agency (AIFA)