Clinical experimentation

Clinical experimentation is a medical study conducted to test the effects of a new medication, of existing medication, of a biological therapy, or of a medical device capable of treating or limiting an identified disease. The main goal of clinical experimentation is to compare two or more groups of subjects, treated with two or more therapies, in order to determine the efficacy of a medication or biological treatment. Clinical experiments can be “monocentric,” when carried out within a single hospital, or “multicentric,” when several Italian or foreign hospitals participate in the study.

Italian legislative decree N. 211 June 24, 2003 defines a clinical experiment as “any study aimed at discovering or verifying the clinical, pharmacological and/or other pharmacodynamic effects of one or more experimental drugs, and/or identifying any adverse reaction of one or more experimental drugs, and/or studying its absorption, distribution, metabolism, excretion, with the goal of ascertaining its safety and/or efficacy.”