An essential part of every medical research in clinical trials – the tests of a health product for humans. They represent a chance for patients to have early access to innovative treatment, as well as an indispensable opportunity for the health professionals to get expert knowledge of this treatment and improve the quality of care.
The purpose of each clinical trial is to clearly identify the advantages and disadvantages of a new treatment for it to take a justified place in the therapeutic arsenal. Clinical trials are essential to the health authorities to control and regulate the use of new treatments. Any clinical trial provides essential elements of understanding of the operating mode of the therapeutic molecule but also on the disease and response to treatment.
CLINICAL TRIALS IN FRANCE: CLINICAL DEVELOPMENT IN 3 STEPS
The clinical R&D spend in France is around €5 billion, at the same time the laws regulating medicinal products policy are very strict, which makes France a very attractive destination for clinical trials. In France, they are conducted in three phases.
Phase I is performed on a limited number of healthy subjects (or in cancer patients), over a short period. The objective is to assess the safety of the product, its behavior in the body, its tolerance, and its undesirable effects.
Phase II is conducted on patients. During this period, medical professionals test the efficacy of the product and determine the optimal dose. These studies are usually comparative: one of the two groups of patients receives the molecule while the other receives a placebo.
During phase III, the treatment is tested on a large number of patients in many study centers. It is done to compare the therapeutic efficacy of the molecule to an already existing treatment or to a placebo.
At the last phase IV, the treatment is tested on the great population on the subject of side effects.
REGULATORY STEPS REQUIRED PRIOR TO RELEASE OF ANY MEDICATION
Led by doctors or hospital staff, clinical trials are the final and most important stage of the drug development process. Their main purpose is to measure its effectiveness and safety. The clinical trials in France do not start until after several years of discovery and development of a new drug, as well as all toxicity tests in vitro and on animals.
These human trials are obligatory, as the animal or cell models cannot be completely applicable to the human race. Clinical trials are first conducted on a small number of patients at the beginning to ensure the effectiveness and non-toxicity of the new molecule.
Clinical development takes place in several successive steps, framed by the French health authorities. It is designed to test the safety, toxicity, risk/benefit ratio, optimal dose, and the target populations of a drug. Based on these results, the new drug will be marketed or not, and in the case where it is marketed, strict prescription requirements will be established.
TWO KEY AREAS OF CLINICAL TRIALS IN FRANCE: CANCERS AND RARE DISEASES
French clinical trials are mostly conducted in the two “flagship” therapeutic areas – cancer and rare diseases.
– 3.9 patients recruited per active center for cancer, which puts France before Scandinavia, Germany, and the UK.
– 4.2 patients recruited per active center in the field of rare diseases. This is higher than the average in the world (3.7) and Europe (3.9).
Cancer and rare diseases are the two areas to benefit from National Plans, the organization that structures the research efforts and integrated the care. These areas attract investment in clinical trials and reinforce French excellence on an international. They plan, however, to extend this strategy to other therapeutic areas, namely, in the following key areas: cardiovascular and diabetes research.
Among other clinical trials in France, there are therapeutic and physiopathologic researches in antiretroviral strategies, pharmacology, immunotherapy, mother-child diseases, HIV and coinfections, virology, infection mechanisms, clinical epidemiology, and others.
HOW TO GET INTO CLINICAL TRIALS IN FRANCE
Although the French medical system is very socialized and closed, it does not prohibit the participation of foreigners in clinical trials. On the contrary, if a person’s case is special and its study could be beneficial for the trials, the scientists would be happy to welcome the person. Still, it is not obvious how one finds adequate trials for their particular case, and how to sign up for them. If you or your closed one need a special treatment not available in your country, make sure to contact Medifrance Solution. We can help you find the necessary treatment, provide all the information about the available trial centers and register you for the treatment.
Based on the materials of www.lir.asso.fr
