The number of applications for clinical trials of medicinal products in Ukraine has increased compared to last year, the Center’s Department of Evaluation of Preclinical and Clinical Trial Materials reports in its annual information note.
Thus, in 2023 the Center received from sponsors 41 applications for the start of clinical trials, and in 2022 – 25. The main therapeutic areas in which clinical trials are conducted are oncology, allergology, neurology, cardiology, and dermatology. In total, as of the beginning of the year, 400 clinical trials are registered in Ukraine – 309 started, 91 approved by orders of the Ministry of Health.
Among other positive trends of 2023 in the field of clinical trials:
- resumption of clinical trials – 3
- resumption of patient enrollment in clinical trials – 8
- return of patients from abroad to approved clinical trial sites in Ukraine – 14 (29 subjects have returned since the start of the war)
- approval of 9 new testing sites (in Kyiv, Dnipro, Vinnytsia, Khmelnytskyi, Zhytomyr, Lviv);
- increase in the number of ethics committees – 390 now, 308 at the start of the war;
The life cycle of clinical trials conducted in Ukraine is maintained through the submission of substantial amendments to clinical trial materials, which demonstrates the applicants' continuous compliance with GCP requirements.
The war also did not stop clinical trial audits – clinical audits of clinical trials are conducted at any stage of their conduct.
The Center’s priorities regarding communication with stakeholders on restoring and improving the quality of clinical trials in Ukraine remain unchanged, the Department assures: responding to inquiries, conducting online and offline consultations, training for investigators and meetings with members of local ethics committees, informing via the Center’s official website and by e-mail, holding training and professional development seminars, etc.
For more data from the report on the conduct of clinical trials of medicinal products in Ukraine for 2023, see the analytical information note on the Center's website at the link https://www.dec.gov.ua/viewe-pdf-file/?url=https://www.dec.gov.ua/?ZG93bmxvYWQ=d3AtY29udGVudC91cGxvYWRzLzIwMjQvMDEvaW5mb3JtYWN6aWpuYS1kb3ZpZGthLWt2LWthLTIwMjMucGRm
