Clinical trials: what are they?
The clinical trial begins after a new molecule (or combination of molecules) has been discovered and tested in the laboratory against a disease, a new medical device, a new technique or diagnostic method (biological test, imaging examination, etc.). .), management or prevention (therapeutic education). Clinical studies will make it possible to determine its safety, tolerance and efficacy, before applying for market authorization (AMM) or CE marking, which is necessary for its marketing.
The sponsor of the study, academic or industrial, poses research hypotheses, then defines and details a specific protocol (number of patients, duration of the study, methods, etc.). For example: “Phase 2 study evaluating the effect of inhaled aromatherapy on chemotherapy-induced nausea and vomiting (CIVN) in patients treated for cancer”. Then, it must receive the agreement of the National Commission for Computing and Liberties (CNIL), the Committee for the Protection of Persons (CPP) and, depending on the category of research (drugs, implantable devices), the National Agency for the Safety of Medicines and Health Products (ANSM).
>> How many clinical trials are currently underway in France? According to the latest ANSM activity report published in November 2020, in France, 813 clinical trials have been authorized for drugs, 99 for medical devices (breast implants, compression stockings, contact lenses, mobile applications, etc. . ) and in vitro diagnostic medical devices (reactive products, self-tests, instruments, software, etc. ), and 168 others excluding health products: nutrition, behavioral sciences, physiology… “About two thirds of these trials are carried by pharmaceutical laboratories and a third by academic teams (CHU, Inserm, etc.)”, observes Thomas Borel, scientific director of Leem (professional organization of pharmaceutical companies).
Clinical trials: who can participate?
Any healthy or sick adult volunteer concerned by the subject of the research. On the other hand, only sick children can, with the consent of their parents, take part in therapeutic trials. The volunteers are recruited by their doctor, others respond spontaneously to an advertisement or contact structures dedicated to clinical and health research, such as Inserm’s clinical investigation centers (CIC). To be integrated, they must meet the criteria of the study (age, sex, type and stage of the disease, medical history, associated diseases) and submit to certain medical examinations (blood test, etc.). Before deciding to participate, participants are informed of the practical terms of the trial, the expected benefits, possible constraints and possible adverse effects, etc. They then give their consent, knowing that they can leave the current study at any time, without needing to justify their decision.
Clinical trials: how does it work?
The clinical trial takes place in several phases. First of all, the molecule (or combination of molecules) is tested for a few months on a small number of healthy volunteers, at very low doses to assess its toxicity. Then, if phase 1 was conclusive, the molecule is administered to a larger panel, of patients this time, in order to assess the tolerance of the drug, then its effectiveness. Finally, if the previous phase is successful, the effectiveness of the new molecule is studied on an even larger number of volunteers, by comparing it to existing treatments (or to a placebo). It is only at the end of these three phases that the laboratory will be able to apply for MA. When the product goes on sale, a final phase of clinical trials will assess its tolerance on a large scale and detect, if any, adverse effects not identified in previous clinical studies.
>> Are the volunteers paid? This is not a salary, but, for adults, reimbursement of any costs (transport, parking, etc.) and compensation are provided for by law, in compensation for the constraints suffered (taking treatment, visits medical examinations, follow-up examinations, hospitalizations, etc.). The terms of this compensation are controlled by the Committees for the Protection of Persons (CPP) and its amount may in no case exceed 4,500 euros over twelve months.
Clinical trials: is it risky?
“Each study is rigorously supervised and must respect medical, ethical and legal standards” insists Thomas Borel. In particular, the test must always be carried out in the presence and under the direction of a doctor. For their part, the volunteers benefit from a preliminary medical examination and they are monitored throughout the duration of the study. Accidents are extremely rare (the last one dates from 2016) and the sponsors of the study are required to regularly inform the National Medicines Safety Agency (ANSM) of possible side effects. It can then interrupt a trial if it considers that there are risks for the participants.
Our expert: Thomas Borel, Scientific Director of LEEM (Medicine Companies)
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