Clinical trials
A clinical trial involving medicinal products is an investigation carried out in humans with the objective of describing or checking the effects of those drugs in order to define their efficacy and safety.
To highlight the relevance of clinical trials, it is important to highlight that almost all currently available treatments are the direct result of clinical research.
These studies represent the opportunity for a new line of therapy for patients who have exhausted all standard treatments.
Phases of a test
Phase I
The study is conducted on healthy volunteers, people in good health who do not have the disease for which the drug is tested. Research focuses on the safety of the drug in humans.
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Phase II
The new drug is given to a limited number of sick patients for a short period of time. The aim is to obtain preliminary information about their safety and the benefits regarding the treatment or prevention of the disease. Unlike Phase I, Phase II patients have the disease they are trying to combat.
Phase III
It is the last link in the process of testing a new drug in humans. When Phase III studies have been completed and the sponsor can demonstrate that the drug is safe and effective under certain conditions, it is ready for approval by the Administration. At this stage, the number of sick patients to whom the new drug is administered is much higher.
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Phase IV
It takes place once the drug is already on the market. It usually measures the long-term effects of the new drug or studies new indications.
Types of test
Open
When everyone involved in the trial knows the treatment being tested.
Blind to
Researchers know the treatment being used, but patients do not know who is being given the drug being tested and who is receiving placebo.
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Double blind
Neither researchers nor patients know who is receiving treatment. Only investigators could become aware of the medication administered to the patient if necessary to protect the patient’s safety.