What is a clinical trial?
It is an international scientific research which develops new treatment methods and analyses their effectiveness. Thanks to that, medicine can keep developing, thus providing help to numerous patients who often suffer from serious conditions.
The medicines of latest generation are more effective and safer. Their main sources are plants, animal organisms and new chemical compounds synthesised in laboratories. In the course of trials, we, first of all, lay emphasis on the patient’s wellbeing, which is why conducting our activities in accordance with the GCP (Good Clinical Practice) standards is of utmost importance.
How are clinical trials conducted?
A period of over ten years is needed in order to prove the effectiveness a new method. There are several phases of extensive clinical trials and each of these must provide a satisfactory result. The following are the phases of trials:
at this stage, we look for the desired natural or synthetic substances with medicinal properties.
at this stage, a new medicine is administered for the first time to a healthy volunteer. As a result, it is possible to examine how the substance is absorbed by the alimentary canal and how it is excreted. These trials also enable analysing the interactions of the new preparation with other medicines or food.
their aim is to confirm the efficacy of the new medicine in a specified group of patients. We also determine the dose of the medicine to be used in subsequent phases. The participants are divided into two groups and, if the benefits resulting from administration of the new preparation outweigh the risks they carry, Phase 3 of the trials begins.
these last from a year up to several years. At this point, the trial group comprises several thousand patients with pharmacological treatment recommendations, whose recruitment is subject to specified criteria. This phase confirms the effectiveness of the substance and results in the substance being approved for application in numerous countries. The necessary data required for preparation of the pharmaceutical information leaflet is gathered during this phase.
these complete the long-term work on a new generation medicine. If the tests in the previous phase prove positive, the product will be approved for sale. The trials also determine whether the product is confirmed by the producer as safe for all the disease groups - this is the final confirmation of the results obtained in the course of trials.
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Safety of medical trials
We always emphasise the importance of our patients’ safety. Each trial is conducted in accordance with Good Clinical Practice standards. These are precisely defined principles, described in Polish and international legal regulations.
The patients’ safety and validity of the trials are supervised by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products as well as the Chief Pharmaceutical Inspectorate. The above mentioned Good Clinical Practice is a code of ethics which informs about the most important rights of the patient.
It states that:
- the patient's wellbeing and safety are superior to the interest of science or society,
- the patient must receive all the information concerning participation in trials and all their questions must be answered,
- the patient gives their free consent to undergoing trials, they can refuse to do so or withdraw the consent at any moment,
- the risk connected with the trials must be lower than the resulting benefits,
- protection of personal data is mandatory during any trial activities.
Participation in a clinical trial
Participation is free of charge and voluntary. A patient qualified for the trial, who meets all the requirements, signs the so-called Informed Consent to Participation in Trial. The process is conducted by a physician whose responsibility is to provide answers to any questions that may arise. It is the physician who decides about participation in the project, which is why it is necessary to express in writing the will to take part in a trial by filling in and signing a form in two copies.
Any person who meets the criteria and suffers from a given condition may participate in a trial. The benefits comprise, first of all, constant medical care from the attending physician and a number of laboratory tests unavailable for other patients. Above all, however, they have the chance to improve their health, which is the most important value.