Clinical Trials in Republic of Bulgaria in the period of 2020-2023

Abstract

Clinical trials are a research method that studies the health and the diseases of the people. In clinical trials an answer to the questions like, how the human body works, how the disease is starting, developing and progressing, how the body can handle a treatment, what can people change in their way of life, so a disease won’t occur is given. The clinical trials can also be called interventional studies because the aim is to learn more about intervention that can be new medication, new medical device, or a new procedure. In these studies, the researchers assigned an eligible participant to test the new product and to get more evidences that it will be safe to use in future. The new product that is tested in the clinical trial can not be used by the doctors as regular treatment of a disease prior to the received approval of it. In the clinical trials the researchers are trying to find people that can met all the eligibility criteria that is required for someone to be part of it, patients of certain age and gender, patients who have a certain disease or a health condition, patients with or without some medical history condition, patients with or without some prior treatment of the targeted disease, patients who are or who are not exposed to something that can affect the condition that is treated. The eligible participants in the clinical trials may or may not get any benefit from being part of the study. During the trial the researches do not have the information if the new treatment can be beneficial, harmful or same as the standard of care for that disease.

Keywords: Clinical Trials, clinical studies, new treatments, new medications, medical devices