Before a new treatment can be made available on the market to all potential patients, it must be deemed effective and well tolerated.
A clinical trial is a type of medical research study conducted on humans at authorized clinical sites, each under the supervision of a physician. This research aims to collect data on the safety and effectiveness of new drugs, medical devices, therapies, and interventions, which will be evaluated by the appropriate regulatory authorities to authorize their marketing and use in clinical practice.
Depending on the stage of development of the product being studied, a clinical study may involve the enrolment of a few dozen to several thousand participants, conducted at one or more clinical sites located in one or more countries around the world. These sites must receive guidance and be coordinated in accordance with applicable laws, in a way that ensures each participant is managed consistently with the others and that the data collected are uniform and reliable.