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Ethics in clinical trials – The situation today

Before new treatments can be offered to patients, it is crucial to ensure that they are effective and safe. This is why clinical trials are a mandatory part of the marketing approval process, both for the registration of new drugs and for the introduction of new indications for products already on the market.  

A clinical trial is a research study in human volunteers carried out to answer specific health questions. It may test a drug, a medical device or an act of surgery.

A majority of clinical trials are carried out on drugs and are sponsored by pharmaceutical companies. Such trials are conducted worldwide and must adhere to the most stringent ethical and methodological standards, as well as complying with all national and international regulations. 

Clinical trials represent one of the essential components in the development of a drug.

They are necessary to identify those patients who will best be able to benefit from therapeutic innovations, depending upon their disease or condition. They also make it possible to determine what adverse events may occur, as well as the drug's dosage and conditions of use. 

For pharmaceutical companies, clinical trials represent a major ethical issue, since drugs are not conventional products and patients are vulnerable in view of their disease or risk factors. Whether a trial focuses on products designed to cure or treat a disease or condition, or preventive products that act on risk factors and make it possible to prevent or delay the occurrence of disease, the trial must protect the safety of participating patients and ensure their consent is based on clear, complete information.  

• Consult the "Clinical development" section on our Corporate website
• Consult the "Clinical trials" section on the F.D.A website
• Consult the Good Clinical Practices of the I.C.H (International Conference on Harmonization)