The Clinical Research Centre coordinates the conduct of clinical trials
Every medicine, medical device (e.g. a method, diagnostic test, research equipment) must undergo clinical trials before it can be marketed and used for patients. In subsequent stages of clinical trials, efficacy and safety are assessed and the optimum dose of the investigational drug is determined. Clinical trials can also be used to test new ways of preventing diseases and guarantee the development of pharmaceuticals and medicine.
Clinical trials are conducted according to strict rules that aim to ensure maximum safety for the patient (the trial participant) and respect for their rights. It is the doctor, who acts as the investigator, who decides whether a patient meets the medical criteria to take part in the trial.
The principles for conducting clinical trials are regulated by existing legal and ethical regulations.
A clinical trial may begin after obtaining the relevant permits, i.e. approval from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) and a positive opinion from the Bioethics Committee.
Participation in a clinical trial is voluntary, requires appropriate preparation and consideration of the decision. The investigator who qualifies patients for the study carefully explains all aspects of the study, which may be unclear or questionable to the participant. A patient who decides to take part in a clinical trial signs an informed consent to participate in the clinical trial.