Clinical trials in Bosnia and Herzegovina: Challenges and future perspectives

Dragana Stanišić; Ahmed Osmanović; Adnan Fojnica; Amina Kurtović-Kozarić

doi:10.1016/j.conctc.2022.100953

Clinical trials in Bosnia and Herzegovina: Challenges and future perspectives

Contemp Clin Trials Commun. 2022 Jun 28:28:100953. doi: 10.1016/j.conctc.2022.100953. eCollection 2022 Aug.

Authors

Dragana Stanišić¹, Ahmed Osmanović², Adnan Fojnica³, Amina Kurtović-Kozarić^{1

4}

Affiliations

¹ Department of Genetics and Bioengineering, International Burch University, Sarajevo, Bosnia and Herzegovina.
² Department of Biology, Olawell Inc., Manchester, MA, USA.
³ Institute of Biochemistry, Faculty of Technical Chemistry, Chemical and Process Engineering, Biotechnology, Graz University of Technology, Graz, Austria.
⁴ Department of Pathology, Cytology and Human Genetics, University Clinical Center Sarajevo, Sarajevo, Bosnia and Herzegovina.

Abstract

Background: Clinical trials (CTs) are research investigations in which participants receive medical treatments, interventions, or tests to assess their safety and efficacy. Each planned clinical is registered through local or national medical agencies, which may differ in the amount of administrative and legal procedures. The objective of this study was to systematically analyze the registration process for clinical trials in Bosnia and Herzegovina in comparison to other Balkan countries.

Methods: The search strategy was based using two online databases: Clinicaltrials.gov (CTGR) and Cortellis Clinical Trials Intelligence (cTi). Search engines included studies until 26^th April 2021 and countries were compared in terms of the number of studies, status, type, funding, clinical phases and demographic data.

Results: The total number of clinical trials from Bosnia and Herzegovina recorded in the CTGR database was 219, while the cTi database comprised 254 registered studies. The total number of reported clinical trials in CTGR and cTi databases were highest in Serbia (n = 1229, n = 1438), followed by Croatia (n = 1142, n = 1300), and Slovenia (n = 801, n = 948), respectively. However, the highest number of clinical trials per capita is in Slovenia (3.85e-4 in CTGR; 4.56e-4 in cTi), followed by Croatia (2.78e-4 in CTGR; 3.17e-4 in cTi), Serbia (1.41e-4 in CTGR; 1.65e-4 in cTi), and Bosnia and Herzegovina (0.67e-4 CTGR; 0.78e-4 cTi).

Conclusion: Our analysis showed that Bosnia has the lowest number of clinical trials in the Balkans. Furthermore, the registration process is complex and longer than in developed countries. Since the healthcare system has been in a transition in the past decade, clinical trials are underutilized as a tool for the improvement of patient care. The clinical trial registration process could be improved by establishing an ethical committee at the state level and by enabling a parallel submission process to ethical committees and databases.

Keywords: Bosnia and Herzegovina; Clinical trial registry; Ethics committee; Low-income country.