FOR PATIENTS

FOR PATIENTS

A rich collection of information that every patient should be familiar with.

CLINICAL TESTS

If the effectiveness and safety of the test substance has been confirmed in the preclinical stage – it is safe for people to take it. The purpose of the evaluation of the impact of the test substance on the human organism is carried out in four phases:

Phase 1. The substance is taken by a healthy young men in order to check the safety of the substance and its action in the human body, because it may turn out that the human body reacts differently than animal organisms. In this phase the potential participants are paid, because they exist difficultness to determine the risk, and the participants as healthy people have no opportunity to benefit from it.

Phases 2. and 3. During these phases the test substance is taken by people with a disorder/disease to treat the test substance, the effect of the substance is compared to the drugs available on the market, the best dose is determined, whether a given substance is more powerful than the drugs used so far. As well the safety and side effects are observed. The test substance will be registered as a medicine if it is more effective and safer than the previously used.

Phase 4. A phase that lasts after registration of the test substance as a medicine, when it is already available in pharmacies, where side effects are still observed, and besides, the action of different doses and forms of drug delivery, e.g. tablets, capsules, drops are compared.

The main essence of clinical trials is to compare the test substance with the previously used drugs.
Clinical trials are conducted using the “double-blind” method, which means that neither the participant nor the physician who is conducting the study knows which of the substances is being compared; one of the previously used drugs, placebo, or a test substance. These substances are granted to participants of the study in a random way, it is called randomization.

This method is used to ensure that the results of the study are not affected by any conscious or unconscious emotions or expectations of the researcher or participant associated with any of the substances.

In order for a test substance to be registered as a medicine, it must be concluded from the results that it is more effective and safer than the one with which it was compared.

After completing a clinical trial, we receive a new drug that is safer and more effective than the ones used so far. The whole process of its formation lasts from about ten to several years.

All information found on the leaflet of the medicine purchased at the pharmacy was obtained during clinical trials.

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