Abstract

Background: The World Medical Association’s Declaration of Helsinki explicitely requires registration of a study involving human subjects before its onset. The registration creates an opportunity for improvement of design and avoidance of bias. Objective: The aim of this article was to elaborate a need for creating regional registry of clinical studies for Balkan countries. Methods: Available international, national and regional registries were searched for in PUBMED database and by general purpose search engines like Google or Yahoo. The following types of publications were included in the survey: original studies, case studies, case reports, narrative reviews, commentaries and expert opinions. Results. The most important international registries of research involving human subjects are „ClinicalTrials.gov“ dabase of US National Institute of Health, the World Health Organization’s „International Clinical Trials Registry Platform“, PROSPERO and Cochrane Database of Systematic reviews and meta-analyses, and the Research Registry, focusing on observational studies. National registries were established in Japan, South Korea, Sri Lanka, China, and others countries, while European Union has the most elaborate of regional registries. National and regional registries performe better than large international ones: the registrations are more complete, and researchers are more aware of their obigation to pre-register a clinical study. Conclusion. There is great need for one regional registry of clinical studies for Balkan countries, which would suit well the whole region, considering great socio-economic, cultural and lingual similarities of the Balkan countries.

Key words: Clinical study, Registry, Risk of bias, Transparency