Patients information

General information on clinical trials

What is a clinical trial?

 

A clinical trial is biomedical research organised and carried out on humans with a view to developing biological or medical knowledge.

 

The purpose of conducting clinical trials on medicinal products is to establish or verify, as the case may be, certain data of a pharmacokinetic (methods of absorption, distribution, metabolism and excretion of the medicinal product), pharmacodynamic (primarily the medicinal product's mechanism of action) and therapeutic (efficacy and tolerance) nature on a new medicinal product or a new way of using a known treatment.

The trial can be conducted using sick or healthy volunteers.

 

To begin, the trial must have obtained a positive opinion from the French Ethical Review Board (CPP) and an authorisation from the French Health Products Safety Agency (ANSM).

The trial's objective, the conditions for carrying it out and its various steps, as well as the procedures for including, informing, treating and supervising the trial participants by the investigating physicians, and the procedures for collecting information on the efficacy and tolerance of the medicinal products are defined in a pre-determined protocol.

 

What information should be provided to people participating in a clinical trial?

 

A clinical trial may not be conducted without first informing the person on whom the trial is being conducted and obtaining that person's informed consent.

 

Before accepting or not accepting to participate in a clinical trial, the person is informed by the doctor conducting the trial or a doctor representing him/her of:

  • the objective, methodology and duration of the research;
  • the expected benefits, constraints and foreseeable risks, including in the event of the research being interrupted before its completion;
  • possible medical alternatives;
  • the medical care arrangements planned for the end of the research, if such care is necessary, in the event of early termination of the research, and in the event of exclusion from the research;
  • the positive opinion of the CPP and the authorisation of the ANSM;
  • his/her right to have access to information concerning his/her health in the doctor's possession, during or on completion of the research;
  • where applicable, any ban on simultaneous participation in other research, or any exclusion period laid down in the protocol and their entry in the national volunteers' file;
  • the right to refuse to participate in research or to withdraw consent at any time without incurring any liability or consequences as a result.

The information provided is summarised in a written document given to the person. Consent shall be given in writing.

 

For each clinical trial, there are specific criteria for including participants.
These criteria are generally based on the person's age, illness and medical history.
The inclusion criteria are not designed to reject someone on a personal basis, but are intended to select participants appropriately so as not to subject them to undue risks if they agree to take part in the trial.

 

Source and additional informationhttp://ansm.sante.fr/

 

Would you like to participate in one of our studies?

 

Visit the page dedicated to our ongoing research projects.

 

 

 

Patients' associations

 

Patient associations exist to support you in your condition.

They constitute a relay of information, and put in place various actions of formation, prevention, moral accompaniment (thanks to groups of speech or permanences) and sometimes legal support (fight against discriminations).

For more information, you can consult:

 

RVO (Retinal Vein Occlusion) patients' association:

 

 

French Federation of Diabetics (FFD):

 

 

 

 

English