Reported clinical trials in Republic of North Macedonia
Kire Stojkovski
PSI-CRO,Sofia,R.Bulgaria
Evgenija Dameska-Stojkovska
UMBAL St Anna, Sofia R.Bulgaria
Vladimir Stojkovski
GOB 8 September, Skopje, Republic of N. Macedonia
Mihail Petrov Mihaylov
Skin Line, Sofia, R. Bulgaria
616-07(497.7)
Abstract
Clinical trials are studies for medical research in which people are involved. All the new treatments need to be deeply and thoroughly tested before they can be approved for usage of the people. Firstly, laboratory tests are made by researchers, if the result of the new treatment give a promising result the new treatment is tested in the population. The Clinical Trials are dived in: Trials of new drugs, trials of new devices and trials of new procedures. There are different types of clinical trials: The main segregation can be the one in which according to the type of the clinical trials are divided as type of investigational clinical trials and type of observational clinical trials. Also, according to the type trials that can be mentioned are: Pilot studies and feasibility studies, Screening trials, Treatment trials, Prevention trials, Multi-arm trials, Case control studies, Cross selection studies, Cohort studies. And the other well-known differentiation of clinical trials is according to the phase in which a study can take place. According to this differentiation there are: Phase 1, Phase 2, Phase 3, Phase 4 clinical trials. However, there are trials that are in phase 0, which is a phase that aims to find out if the new treatment can reach to the targeted cells and will have some effect. Also, there are clinical trials who are in phase that is not defined by FDA. This are trials of behavioral interventions or trials in which devices are tested.
Keywords: Clinical Trials, phases, types, clinical research
ISSN 2955-2117
EISSN 2955-2133
Journal DOI https://www.doi.org/10.59710/oaijoaru
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Publisher: Association of Traditional Chinese Medicine and Acupuncture Tong Da Tang TCM, Skopje R.N. Macedonia
E-mail: oaijar.universes@gmail.com oaijar.universes@outlook.com