What are clinical trials?
Clinical trials help researchers better understand how a drug works. Their purpose is to prove whether a substance is effective and, above all, safe for patients with a given disease. Different treatments for the same disease are also often compared to help determine if there are cheaper and more effective options to help improve patient care.
Why are clinical trials necessary for us?
In order to be sold on the market, each drug must undergo and pass all phases of clinical trials. This rigorous process helps ensures that teatments available to the general public are safe and effective to help treat disease.
Clinical trials are carried out according to strictly defined rules included in the trial protocol. Proceeding in accordance with the protocol ensures maximum patient safety. A qualified doctor who specializes in the field of study is responsible for the patient’s qualification for the examination and will monitor the trial progress to ascertain the highest possible safety for participants in the study.
Joining a clinical trial is voluntary. The researcher recruiting patients for the study is obliged to thoroughly explain all risks to the participant in the study and answer any questions that may arise. A patient who decides to take part in a clinical trial signs a clinical trial subject’s informed consent form in order to be enrolled into the study.
Control over the clinical trial process
In Poland, clinical trials are supervised by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The relevant Bioethics Committees give opinions on the ethics of a clinical trial to make sure that all interventions are done to the safest standards for participants and only necessary procedures are carried out.
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Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych