Clinical Trials in Republic of North Macedonia in the period of 2018-2023.

Abstract

Clinical trials are studies that can determinate the efficacy and the safety of new drugs, treatments, or medical devices. The trials are verification that something new is helpful for patients and it would not cause any injury or adverse event. The differentiations in the clinical trials are firstly of what is going to be examined, is it new drug, new medical procedure, or new medical device. Another way to divide the clinical trials is depending on the phase in which the clinical trial is taking place. There are four phases of the clinical trial, The first phase is to determinate if the new way of treatment is safe, usually it is done on healthy volunteers. The goal of phase two is to be found out the right dose and effectiveness in treating diseases, usually it is done on a wide group of volunteers who have the targeted disease. The main goal of the third phase is to give answers if the new treatment can produce good results on a big group of volunteers, If the result will be better than the previous standard of care. The fourth and the final phase of the clinical trials is done after the new treatment is approved for usage. In this phase new not reported rare adverse events are investigated.

Keywords: Clinical Trials, Phases of clinical trials, studies, new treatments, new medicine