- Phase I – includes safety tests of the tested substance evaluated in a group of several healthy volunteers, where their metabolism, absorption, possible toxic effects and interaction with the substances taken are studied
- Phase II – assesses the safety and efficacy of the tested substance in a specific group of patients; the relation between the amount of the dose administrated and the action effect is also evaluated in this phase.
- Phase III – the final confirmation of the efficacy of the tested substance in the treatment of a given specified, evaluated in a large group of patients.
- Phase IV – consist of clinical research conducted on drugs or medical devices that have already obtained approval, also named post marketing studies. In this phase, it is also possible to assess new indications for previously registered medicinal products.
A special kind of clinical trials is bioequivalence studies that are conducted for generic medicinal products (generic drugs, substitutes). The aim of these studies is to confirm the pharmaceutical and clinical equivalence of a generic medicine with an original medicine in a group of healthy volunteers.
Clinical trials are carried out in an objective and accurate manner to confirm whether a given medicine or medical device is safe and effective. Participants in clinical trials are subjected to detailed tests and observation. Each registered clinical trial is conducted after obtaining a positive opinion of the Ethics Committee, in accordance with the guidelines of Good Clinical Practice (GCP) and legal regulations. Clinical trials are carried out by a team with the appropriate education and experience in conducting this type of research: specialist doctors, research coordinators, monitors, pharmacologists, as well as a medical and nursing team.
What are the benefits of clinical trials?
- Participant access to innovative therapies and treatments,
- Participation of patients in research programmes,
- Participants receiving free care provided by qualified medical personnel,
- Detailed monitoring of health status during the tests,
- Helping others through the personal contribution to the development of medical science.
Who can take part in a clinical trial?
Clinical trial participants are recruited on the basis of inclusion criteria, which are detailed in the protocol of each trial.
Depending on the phase of the study, specific groups of participants can be eligible: healthy volunteers or people with a specific disease.
What are the responsibilities of a clinical trial participant?
The participant applies for the trial voluntarily by signing an informed consent form participation in the trial. Participation in a clinical trial requires that the participant adheres to the doctor’s recommendations, attends follow-up visits, and informs the doctor of any ailments that arise in the course of the test.
Is it possible to withdraw from participation in a clinical trial?
A participant may withdraw from a clinical trial at any time, without incurring any consequences. Before making a decision to withdraw, it is worth consulting the doctor conducting the research, who will answer all questions to dispel the participant’s doubts.