Clinical trials are medical research studies conducted to test the effectiveness and safety of new ways to prevent, detect, or treat diseases. In the case of new treatments, these could be new medications, new drug combinations, or innovative ways to use existing treatments.
Clinical trials allow for the verification of the real effects, effectiveness (producing the desired outcome), and safety of new treatments in humans.
Thanks to volunteers, researchers can conduct clinical trials approved by health authorities, and with their results, gain a better understanding of how to diagnose, treat, and prevent diseases.
Participating in a clinical trial contributes to advancements in the treatment of many diseases and represents the opportunity to access new treatments for people who have undergone available therapies for their condition without the expected success.
Currently, our specialists are involved in various national and global reference studies.
To learn about the clinical trials we are currently conducting, follow this link
, select Ruber Internacional Hospital in the "Select center" window, and search for the disease or medication of interest.
In the future, when you see or read news about a medical breakthrough due to the effect of a new medication, remember that, in addition to the work of all the researchers, thousands of volunteers contributed to that advancement by participating in clinical trials.
Clinical trials are not the first step.
Testing a new treatment or procedure on humans is not the first step in research. Human studies (clinical trials) are conducted only after the results of laboratory studies (preclinical), conducted on cell lines, animal models, etc., have concluded that the new treatment or medication could be effective and safe for humans.
Animal studies are highly regulated, consist of several well-defined evaluations, and are carried out with different species. The preclinical development of a new drug can take years to complete, and only if it is scientifically demonstrated that the treatment could be beneficial for humans will clinical development begin, which involves submitting an application for the investigation of a new drug to health authorities and regulatory bodies.
Phases of a Clinical Trial.
The study, evaluation, and development process of a new therapy consists of four phases or stages. In the early phases, very few people are involved, and the number increases as the trial progresses and it is confirmed that the benefits of the developing drug outweigh any potential risks or side effects.
Phase I
Evaluates the safety of the drug. It is usually conducted in a small group of volunteers and allows for the evaluation of how the drug acts in the body, how it is absorbed, metabolized, and its best method of administration. Initially, volunteers receive low doses of the treatment, and the results are assessed. If everything goes well, the process continues until the dose of the drug that works with the minimum level of side effects is found.
Phase II
Evaluates the effectiveness of the treatment. It involves a larger number of volunteers (25-100) and aims to determine the effective dose and the side effects of the treatment.
Phase III
Includes a large number of participants (hundreds to thousands) from one or several countries. It allows for a deeper investigation into the effectiveness and safety observed in Phase II and determines the incidence of any potential side effects. The results obtained are compared with those from existing treatments.
If all the results show that the new drug is more effective or safer than the existing treatment, approval is sought from the competent authorities for its clinical use. After review and approval, the new drug becomes available for doctors to prescribe to their patients.
Phase IV
Even after being approved and available for clinical use, medications are monitored for their performance over an extended period. Phase IV trials are studies involving thousands of patients, designed to evaluate long-term effectiveness and safety.
