The objective of clinical trials is to improve patient care and treatment at all stages of disease. They assess the efficacy and safety of new treatments before these are offered to all suitable patients.
These new treatments may be new drugs, combinations of drugs, new ways of administering them or new treatment techniques (surgery, radiotherapy). Clinical studies may be initiated by the pharmaceutical industry, groups of cooperating centres or Gustave Roussy itself.
In all cases, these studies have obtained regulatory approval; they follow rigorous scientific protocols and, in accord with ethical principles, do not infringe the rights of the individuals taking part in them.
The stages of clinical trials
Clinical trials normally proceed in 3 stages:
- Phase I or early trials
The purpose of these trials is to determine the dose and the side effects of a new drug, which may or may not be combined with other treatment. This phase is essential to ensure that correct doses will subsequently be employed.
- Phase II trials
The dose and the administration regimen having been defined, the efficacy of the new treatment is then evaluated on a group of patients who all have the same type of cancer.
- Phase III trials
This is the key trial to confirm the efficacy of the treatment and to justify its subsequent authorisation for use and reimbursement by the Health Insurance system. These trials are always "randomised", which means that lots are drawn to choose between more than one treatment. Typically, the "randomisation" is made between the treatment to be tested and either a conventional treatment or, if no effective treatment is known, a "placebo" (a dummy medicine).