What is a clinical trial ?

A clinical study or trial allows to collect, under strict medical supervision, within the bounds of the law and according to a particular protocol, various information about the investigational product, either a new drug, or a drug that already exists.

Which parties are involved in a clinical trial ?

The sponsor is the pharmaceutical company which has developed a drug to treat a given disease, with intent to market it.

The investigator is the qualified physician in charge of conducting a clinical trial.

The healthy volunteer is a male/female without any diagnosed disorder, willing to participate in a clinical study.

The patient volunteer is a male/female who accepts to help therapeutical progress of the disease he/she is suffering from.

What are the regulatory requirements ?

Since August 27th 2006, France has been implementing the EU Clinical Trials Directive 2001/EC into national legislation (application decree n°2006-477 dated 26 april 2006) detailing new rules on good clinical practice for investigation of medicinal products.

An advisory committee - the CPP (Comité pour la Protection des Personnes), an independent body constituted of medical, scientific and non-scientific members - warrants the protection of the rights, safety and well-being of human subjects involved in a trial .

The AFSSAPS (French health security agency for health care), a dependency of the French Ministry of Health, grants permission to perform a study.

The subject voluntarily confirms his/her willingness to participate in a trial, after having been informed of all aspects that are relevant to the subject’s decision in participating. With the investigator, he/she documents his/her informed consent by means of a written, signed and dated informed consent form.

Les Bonnes Pratiques Cliniques (BPC) réunissent les procédures qui assurent la sécurité des volontaires/patients et garantissent l’authenticité et la qualité des données scientifiques.

The Good Clinical Practice (GCP) is "an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects".

A request for authorization by the CNIL (a national committee for data protection) aims at ensuring the subject’s anonymity and the confidentiality of collected data.

Should I participate in a clinical trial ?  

By participating in a clinical trial, you may learn more about your condition and you can help to move medical knowledge forward.

Research centres like Centre CAP play an active role in the early detection of diseases since all volunteers undergo a rigorous medical prior to being selected to take part in a trial.  

How do I enroll in a clinical trial ?

If you are healthy, you can be recommended a clinical trial. Prior to screening, you must absolutely fulfill 2 conditions :
to be of age
to be a national insurance contributor. 

Is there a financial compensation ?

In order to compensate for the restraints the study may involve, a grant is paid and, according to the French law, cannot exceed 4 500 € per year.
However, only studies which do not lead to a therapeutic benefit for volunteers are compensated.

Where do the studies take place ?

The studies take place in the premises of Centre CAP, within the bounds of the Clinique Rech, in Montpellier.
If you are interested or if you wish to know more about future studies, please call 33 (04) 99 23 22 21, Monday to Thursday, 8:30 am to 6:30 pm and Friday, 8:30 am to 5:00 pm.