A RETROSPECTIVE ANALYSIS OF CLINICAL TRIAL APPLICATIONS IN NORTH MACEDONIA (2022-2024): PHASES, THERAPEUTIC AREAS, AND SITE DISTRIBUTION
Eljona CHILKU, Marija TRAJCHULESKI, Arlinda HAXHIU ZAJMI
Abstract
Aim: This study analyses the trends of clinical trial applications in North Macedonia from January 2022 to December 2024.
Method: The data were extracted from two primary local sources: the public registry of clinical trials in North Macedonia and the internal database of the Agency for Medicines and Medical Devices.
Results: A total of 82 clinical trial applications were submitted during this period, 38 applications are for clinical trials and 44 bioequivalence (BE) studies applications. The clinical trials were categorized by study phase, therapeutic area, and trial site location. In all three years the majority of applications were for Phase 3 studies (45%), followed by Phase 1 (26%), than Phase 2 (18%), and Phase 4 (11%). In terms of therapeutic areas, clinical trials in the area of Neurology are the greatest (7), followed by Oncology (6), Dermatology (5) and Pulmonology (5), Gastroenterology (4), Haematology (4), Cardiology (2) and Rheumatology (2), Endocrinology (1), Nephrology (1) and Antibiotics (1). All submitted studies were multi centric, having prior approval in other countries. Regarding trial site distribution, 21 of the clinical trials were approved for a single site in North Macedonia, as well as 44 BE studies, while 17 clinical trials are conducted in multiple sites. Geographically, 27 of the clinical trials and 44 bioequivalence (BE) studies were conducted exclusively in Skopje.
Conclusion: The findings indicate a modest level of clinical trial activity in the country. To enhance clinical research engagement, aligning North Macedonia’s clinical trial legislation with European Union standards could improve regulatory efficiency and attract more sponsors.
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