Clinical trials

What are clinical trials?

Clinical trials constitute a way of finding new and innovative treatments to improve human health, alleviate the symptoms of a disease or cure it. Clinical trials are conducted with human subjects to confirm the clinical, pharmacodynamic and pharmacological effects of a medicinal product and to confirm the safety, efficacy and effectiveness of tested drugs, therapies or medical procedures. They are also supposed to identify adverse effects that a given medication may cause.

The first and foremost priority of any clinical trial conducted is the safety of the Patients who take part in it. Clinical Trials are conducted in strictly defined conditions, according to the trial protocol that describes all procedures, stages of the trial and evaluation criteria. Before the trial starts, the protocol must be reviewed by external safety authorities and receive a positive opinion from the Bioethics Committee and approval from the relevant authorities to ensure the protection of the rights and safety of the trial participants. Before entering the trial, each participant goes through the process of signing an Informed Consent to Participate in the clinical trial, during which they are familiarised with all aspects of the trial. Most importantly, the trial participant has the right to withdraw from participation at any stage of the trial without suffering any consequences.

The path of a new medicinal product is very long and before a clinical trial is conducted with humans, the investigational medication/drug undergoes a series of tests and studies in laboratories to assess its safety and applicability in humans. Any tested substance that has a potential to become an effective drug goes through four different phases of clinical trials conducted under the supervision of scientists and doctors.

Phases of a Clinical Trials

Phase I – this is the phase in which the tested product is administered to humans for the first time in order to evaluate the subsequent desired dose, assess side effects and see how the body reacts to the therapy. This phase usually involves healthy volunteers or patients who have used all possible treatments for a given disease.

Phase II – when the tested product moves into the second phase of clinical trials, its efficacy is tested. This phase of trials is conducted with patients suffering from a specific disease, which is a future therapeutic indication. The management of adverse events is tested and a safe dose for the patient is established.

Phase III – this phase of a trial is conducted on a much larger scale and involves several hundred to several thousand participants. The main purpose of this phase is to compare the performance of the new medicinal product to the available therapeutic standard to see if it exhibits greater benefits than the currently known drugs. If it proves to be more effective than the standard therapy and the tested product proves to be safe for use, it may be approved by the regulatory authorities and be sold in pharmacies, becoming in this way a new standard therapy.

Phase IV – this phase of a trial is conducted after a new medicinal product has been introduced to the market, its purpose is to gather information on the long-term efficacy and safety of the medication/drug when used on a much larger population of subjects compared to the previous phases.

Why are Clinical Trials essential for us?

Clinical trials are a key element in the development of medicine and pharmacy, making it possible for new therapeutic and preventive methods to develop. By participating in clinical trials, each participant contributes to the progress of medical science, gaining at the same time an  opportunity to access modern therapies that may become standard treatment for future generations.

At our Centre, the Clinical Trials are carried out by a qualified and experienced Team of Researchers – Specialist Doctors, Coordinators and Nurses. We conduct clinical trials in accordance with the standards of GCP and the guidelines of national and international law. We fulfil the Sponsor’s requirements, acting also on the basis of our own Standard Operating Procedures, which ensures the highest quality of Clinical Trials.                      

FOR MORE INFORMATION, PLEASE SEE THE LINKS BELOW:

Ministry of Health

 https://www.gov.pl/web/zdrowie/badania-kliniczne
 https://pacjentwbadaniach.pl/

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

http://www.urpl.gov.pl/pl/produkty-lecznicze/badania-kliniczne

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