What is clinical research?
Clinical Research is “research on human beings whose goal is the improvement of human health.” The purpose of clinical research is to increase our knowledge of diseases, investigative methods and treatments, all vital elements to achieve progress in the field of medicine.
A clinical trial may also focus on improving an existing treatment or its comparison with another method of treatment. It is an essential platform for the development of new diagnostic, therapeutic and preventive strategies. All drugs used, whether for common or more specialized treatments, were discovered through research.
Basic research, whose only aim is to further scientific knowledge without any distinct benefits always precedes clinical research.
If a molecule appears to be promising for human application, it must then be tested in a clinical setting where its effectiveness and toxicity will be verified. Clinical studies follow a strict methodology regulated by law and can only take place under specific conditions.
Three phases must be performed before a new medication can be commercialized.
• Phase I: The objective of a Phase I is to verify experimental hypotheses, find the optimal dosage, study how the body metabolizes the drug (changes in the body over time, tolerance and toxicity), determine the best prescription mode and identify side effects. A very small number of healthy subjects (between 20 and 80), or patients for whom all other treatments have been ineffective are placed under constant medical observation.
• Phase II: The Phase II allows the evaluation of the therapeutic action and toxicity of different doses of the product on a small number of people (usually a few hundred). The minimal dosage required to obtain a therapeutic effect as well as the maximal non-toxic dosage for humans are determined. This Phase usually takes place in a hospital setting to ensure close medical supervision of the participants.
• Phase III: A Phase III trial aims to demonstrate the therapeutic value of the drug tested and its lack of harmfulness. Experimentation on the therapeutic activity of the given product is extended to a larger number of subjects (up to several thousands) and is compared to standard treatment, if one exists, or to a placebo (if there is no standard? therapy). This phase is the final step before the drug is available to patients.
It is through clinical research trials conducted since the 1970s that breast cancer treatment has experienced its most important medical advances in the last forty years, from radical mastectomy to personalized treatment. It is a result of the structured and rigorous scientific methodology of clinical research that data was collected in large quantities and treatment protocols were established based on collective and scientific knowledge. Clinical research has therefore proven to be the most powerful lever in refining breast cancer treatment over time in addition to enabling the development of screening and health promotion programs.