What happens during the clinical trial ? Damien Goodhealth
Each clinical trial is conducted according to specific predefined procedures, which guarantees the validity of the results obtained. All research participants must therefore comply strictly with the instructions they are given. Docteur Prudent
What happens at the end of the trial ? Damien Goodhealth
When a trial ends, volunteers are usually not allowed to participate in any further trials for a given period of time, known as the "exclusion period". The duration of this period varies depending on the conditions of the trial and is given during the initial information visit. It applies to all clinical research conducted in France. According to the French Law No. 2002-303 of 04 March 2002, at the end of the research, the overall results are communicated to every persons who so desire. Docteur Prudent
Are the volunteers paid for their participation in a clinical trial? -Damien Goodhealth
Clinical trials in healthy volunteers are usually subject to compensation. Its amount depends on the restrictions undergone (acts performed, duration, time spent in hospital ...). Currently, the maximum compensation allowed in France, for any trial, is 4,500 Euros per year. Docteur Prudent
How are selected the volunteers for a clinical research? Damien Goodhealth
When a clinical trial is initiated, we search our computer database for suitable participants, i.e. persons that meet the criteria defined in the research protocol. We then contact the suitable persons to offer them to participate. Therefore, the contact details of the volunteers must be up to date at all time, and we ask them to inform us of any change in their address or telephone number. Docteur Prudent
How does the informed consent work ? Damien Goodhealth
During the protocol information visit, the study doctor gives a clear and detailed presentation of the study to the volunteers, who are then encouraged to ask any questions they might have. Any person participating in the research must have been informed of the restrictions and risks associated with the trial. Only then, the volunteer can sign the informed consent form. Of course, the volunteers are free to change their mind and withdraw their consent at any time. According to the French Law No. 88-1138 of 20 Dec 1988 and the European Union Directive, a clinical trial can be initiated only after its approval by an ethics committee (IRB: Institutional Review Board) and the relevant French regulatory authority (ANSM: the National Agency for the Safety of Drugs and Health products). Docteur Prudent
How does the inclusion in a protocol work ? Damien Goodhealth
Once a volunteer is selected, they undergo a medical consultation before the inclusion. Depending of the results of the consultation, the participation to the study is confirmed or not. Docteur Prudent
La participation à l'essai clinique est-elle indemnisée ? Damien Goodhealth
Les essais cliniques pratiqués chez le volontaire sain font généralement l'objet d'une indemnisation. Son montant dépend des contraintes subies (actes réalisés, durée, temps d'hospitalisation...). En France, l'indemnisation maximale autorisée, tout essai confondu, est actuellement de 4500 euros par an. Docteur Prudent