What is a clinical study?

 

A clinical study is a scientific study carried out in humans to evaluate the efficacy and tolerance of a product, whether it is a drug, a food supplement, a medical device or a diagnostic test.
It is therefore a necessary step for a new product to be approved, launched on the market and made available to patients.

A clinical study is, of course, only carried out if non-clinical experimental studies (on animal or cell models) have previously shown positive results and a sufficient safety profile for the product to be tested in humans.

A clinical study requires the approval of the ethics committees and the health authorities of the country where it takes place. Ethics committees and authorities ensure that the volunteers’ rights and safety are respected. Studies can only start after they have been approved.

In a clinical study, subjects agree to participate voluntarily by signing an informed consent form and are enrolled by investigators – doctors most of the time.

The investigator follows the volunteer for the entire time the new product is tested and used by the subject. This monitoring is carried out in accordance with a precise protocol approved by the authorities. The study can last several weeks, several months or even several years depending on the product which is tested. The volunteer can leave the study freely at any moment.

A clinical study can be performed on a small number of volunteers or conversely on thousands of people. Many doctors from all over the world can choose to participate as well.

The results of a clinical study are generally published in medical journals and can be used to put together the marketing-authorization application dossier of a product. The anonymity of the volunteers is respected at all times.