Clinical Trials: Conduct, Safety and Ethics
Clinical trials are essential studies carried out to evaluate the efficacy and safety of new treatments, be they drugs, medical devices or new surgical procedures.
Why participate in a clinical trial? An invaluable contribution to research
Clinical trials are essential studies carried out to evaluate the efficacy and safety of new treatments, be they drugs, medical devices or new surgical procedures. Participating in a clinical trial means making a direct contribution to the advancement of medical research and the improvement of health for all.
How is a new treatment tested?
Before human trials: Treatments are first tested in the laboratory and, where appropriate, in animal models to ensure their potential and safety.
Phase I: This first phase aims to assess whether the treatment is well tolerated in humans. The number of participants is very limited (20-50), and they are closely monitored for any adverse reactions.
Phase II: This phase seeks to determine how the treatment works and to assess the benefit-risk ratio. A larger number of participants are involved, as the treatment has already demonstrated its tolerability.
Phase III: Hundreds or even thousands of participants are recruited to compare the new treatment with either a placebo or an existing treatment. If the results show real efficacy, a review by regulatory agencies (such as the European Medicines Agency - EMA) is necessary to authorize marketing.
Phase IV: Once the treatment has been approved and marketed, further studies are carried out to continue monitoring its long-term safety and efficacy.
Safety and ethical measures: maximum protection for participants
If you want to take part in a clinical study, your safety is the top priority of the doctors who will be monitoring you. Here's how we ensure it:
Information and informed consent: You are fully informed of the benefits, risks and planned activities before you sign an informed consent form. Nothing is hidden.
Freedom to withdraw: You are free to stop participating at any time, without justification.
Rigorous follow-up: Any health problem arising during the study is immediately taken care of by the investigators, who ensure that it is not related to the treatment being tested.
Strict regulations: Strict rules protect your safety, well-being and the confidentiality of your data. An independent ethics committee oversees every stage of the trial to ensure these standards are met. Government agencies, such as France's Agence Nationale de Sécurité du Médicament (ANSM), approve protocols and procedures upstream, and monitor trial execution.
Total transparency: The study protocol, data analysis and results are accessible and published to guarantee complete transparency.
Why take part?
By participating in a clinical trial, you play a crucial role in medical progress. You're helping to discover new treatments that could one day save lives or improve quality of life for millions.