In Q2 2024, there is a trend toward stabilization in the number of applications for clinical trials of medicinal products amid the full-scale military aggression of the Russian Federation.
This follows from the “Information note on the status of clinical trials in Ukraine in the period from April 1 to June 30, 2024” published on the website of the State Expert Center: http://surl.li/rbqtzn
“Letters from applicants regarding the start of clinical trials began to arrive – 25 for the first half of the year, including 11 clinical trials in the second quarter. The number of applications in the second quarter stabilized compared with the number of applications in the second quarter of 2023,” the background note says.
According to the Department of Expert Evaluation of Preclinical and Clinical Trial Materials of the Center, as of July 1, 358 clinical trials were being conducted in Ukraine at various stages, of which 277 had been started and 81 had been approved by the MoH for conduct.
In addition, during the second quarter of the current year, the sponsor resumed patient enrollment in 2 clinical trials (neurology, psychiatry).
In total, in the second quarter, notifications were received before the start of clinical trials in the following nosologies: dermatology – 2, neurology – 1, oncology – 2, gastroenterology/proctology – 2, nephrology – 1, psychiatry – 1, as well as bioequivalence studies – 2.
102 trial sites were recommended for approval for new clinical trial protocols and for those introduced by substantial amendments to clinical trials already started. In particular: 29 – in Kyiv and Kyiv region, 10 – in Chernivtsi, 7 – in Lviv, 6 each – in Vinnytsia, Uzhhorod, and Ivano-Frankivsk, 5 – in Zhytomyr, 3 – in Khmelnytskyi, 4 – in Dnipro, 2 each – in Kropyvnytskyi, Rivne, and Lutsk, 1 each – in Cherkasy, Poltava, Kremenchuk, and Kryvyi Rih.
At the same time, due to martial law in the country, in the second quarter of this year 8 letters concerning the transfer of subjects to other trial sites were processed. 8 patients were transferred: 1 within Ukraine, 2 to Poland, 1 to Czechia, 1 to Israel, 1 to Bulgaria, 1 to Moldova, 1 to Germany.
