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What is a clinical trial ?
A clinical trial is a scientific study that uses human subjects to evaluate the effectiveness, the possible side effects and the safety of diagnostic tools and treatments. It provides new scientific knowledge which helps to further understand disease(s), leading to more effective treatments for patients.
Are clinical trials directly performed with human subjects?
Clinical trials are preceded by fundamental research in laboratories in order to evaluate the different parameters, such as effectiveness, side effects and safety of new diagnostic procedures or treatments for a given disease. New methods of diagnosis or treatments that prove to be safe and promising are subjected to clinical trials on human subjects.
What are the legal obligations before beginning a clinical trial?
Before the beginning of a clinical trial, ethics committees et les health authorities of the country where it is to take place give their opinion and their authorization. Its implementation is highly controlled and follows specific laws (like the law for the modernization of healthcare recently passed in France).
Who carries out the clinical trials?
The clinical trials are conducted by doctors and healthcare professionals who have studied the diseases, the methods of diagnosis and the difference stages in the development of the medication, and who have been trained in good, bioethical clinical practices.
What is the role of research teams in clinical trials?
Through these clinical trials, researchers offer patients the opportunity to be diagnosed using new methods and/or to be treated with promising new treatments. Patients or healthy volunteers are chosen according to inclusion and exclusion criteria. Researchers should communicate to the enrolled participants both the benefits and the potential risks of the clinical study. All the important information about the study must also be given to the potential participants in a written document, as well as a consent form that the participant must sign before being enrolled. Patients or healthy volunteers may withdraw their consent at any given time.
The researchers then include patients and healthy volunteers in clinical trials and follow them throughout the study. Nurses involved in the clinical research project, as well as the team from the department of medical research, are available to answer patients’ questions and to follow the clinical trial to document both its benefits as well as undesirable side effects.
What are the conclusions of clinical trials?
The results of clinical trials are published in medical journals and are presented during national or international conferences. In the case of medications these clinical trials make it possible to build a solid file that allows its marketing authorization (AMM). In the case of clinical trials demonstrating the advantages of the new methods of diagnosis, the management of new patients is improved.