Abstract
Endocrine system diseases (ESD) occupy one of the leading places in the structure of the general morbidity of thepopulation. Recent events have had a significant impact on the healthcare system in Ukraine, including the treatment of ESD and the conduct of clinical trials (CTs). Aim. Analysis of information about CTs of ESD in Ukraine. Material and methods. Descriptive analysis was conducted on the ClinicalTrials.gov website database using the keywords «Endocrine System Diseases» in the «Active, not recruiting» and «Re cruiting» groups. Results. Information is presented on 17 CTs of ESD in Ukraine according to the ClinicalTrials.gov website database as of January 25, 2024, 13 of which had the current status of «Active, not recruiting» and 4 – «Recruiting». The average duration of these 17 CTs is 5 years and 6 months, with 2 of them running for more than 10 years. The total number of CT participants was 28 710 people (minimum – 48, maximum – 13 299, average – 1689). 14 CTs were interventional, 3 studies were observational prospective (2 case-control and 1 cohort). Allocation for 12 CTs was randomized. According to the type of intervention model, 12 CTs were assigned in parallel groups and 2 were assigned in single groups. No masking was used in 7 CTs, 2 CTs were double-blind, 1 CT was triple-blind and 4 CTs were quarter-blind. The main purpose of 14 CTs was treatment.
Phase II of the study was indicated for 4 CTs, phase III – for 9 CTs. CTs were conducted in 58 countries, and the average number of medical facilities was 116. In Ukraine, 35 medical facilities were the bases for conducting CTs. The undisputed leader in terms of the number of CTs (10 out of 17 or 58.8%) is the State Institution «V.P. Komisarenko Institute of Endocrinology and Metabolism of the National Academy of Medical Sciences of Ukraine». 4 CTs are held exclusively in Ukraine. CT was sponsored by 8 commercial and 2 state organizations. Conclusions. As of January 25, 2024, the website www.ClinicalTrials.gov published information about 17 CTs of ESD in Ukraine («Active, not recruiting» – 13 and «Recruiting» – 4). In recent years, a negative trend has been observed in conducting CTs in Ukraine. The stability of the system in most specialized institutions of Ukraine and the rapid restoration of the level of providing high-quality special care indicate good prospects for restoring the status quo.
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