Clinical trials are an important, constantly developing part of medicine.
It is thanks to clinical trials that we now have access to modern therapies.
By deciding to participate in a clinical trial, you receive:
Extensive diagnostics and free tests, often unavailable in primary or even specialized medical care
Systematic monitoring of health condition by highly specialized medical staff
Guarantee of treatment in accordance with international standards
A chance to prevent troublesome and difficult-to-cure diseases, including those where standard therapies do not produce results
The possibility of receiving a new medicament that may help many patients in the future
Free access to treatment of various diseases
Reimbursement of travel costs for follow-up visits during participation in the study.
During clinical trials, the patient's well-being comes first.You have the right to withdraw your consent to participate in the research at any time.
Clinical trial definitions
Patients often wonder how they know that the medicaments prescribed by the doctor will work, that they are safe, in what dose and how often they should be taken, and where the information about side effects listed in the medicament leaflet appeared.
The answers to these questions are learned during a clinical trial, i.e. a process in which a molecule that is not yet a registered and approved medicament is assessed in terms of the safety and effectiveness of the treatment.
What is a clinical trial?
A clinical trial is a scientific study, conducted with the participation of humans, aimed at discovering or confirming the clinical, pharmacological, including pharmacodynamic effects of one or more investigational medicinal products. Clinical trials are also conducted to identify adverse reactions and to monitor the absorption, distribution, metabolism and excretion of one or more investigational medicinal products with a view to their safety and effectiveness.
Why do we need clinical trials?
Each medicament must undergo clinical trials in order to be approved for sale and use by patients. The tests are aimed at confirming or excluding the effectiveness of the test substance, determining the safety of use, and establishing appropriate dosage regimens for selected target groups of patients. The most important and superior to the interests of science and society are the rights, health and safety of research participants. The benefits of using the test substance must outweigh the risks for the research to proceed.
Clinical trials concern every new medicament that is to enter the market and be approved for sale, as well as new applications for already registered medicaments. Conducting research is possible only after obtaining permission from the regulatory body - the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB) and obtaining a positive opinion from the Bioethics Committee.
Please note that clinical trials do not apply to dietary supplements. According to applicable regulations, dietary supplements are defined as foodstuffs. Putting them on the market for the first time in Poland requires only submitting a notification to the Chief Sanitary Inspector.
Source: https://pacjentwbadaniach.abm.gov.pl
Clinical trials allow for testing the effects of new substances, as well as new combinations of already known substances. The most promising ones are tested in the laboratory and then tested on humans in 4 phases.
Phases of research involving patients:
Phase I – determines the potential toxicity of the medicament, the minimum and maximum dose, and all pharmacological features of the future medicament (e.g. how the substance is excreted from the body, how long it works). Research in this phase is conducted exclusively on volunteers.
Phase II – confirmation of the effectiveness and safety of the drug in a given disease. This part of the research is conducted on a small group of patients (several dozen people).
Phase III – researchers confirm the effectiveness of the medicament in a given indication on a large population of patients (several hundred or even several thousand people), and at the same time, the safety of the given therapy is checked. It is also verified whether a given medicament is more effective than the previously used standard.
Phase IV – conducted after marketing authorization. This step is to determine whether the medicament is safe for all indications recommended by the manufacturer and for all patient groups. Verification of the results obtained in the previous stages is also carried out.
At the Clinical Research Centers, we conduct phase II, III and IV clinical trials.
Source: https://pacjentwbadaniach.abm.gov.pl