The Department of Preclinical and Clinical Trials Expertise of the State Expert Center (SEC) of the Ministry of Health of Ukraine, in its annual information report, informs that the number of applications for conducting clinical trials of medicinal products in Ukraine has increased compared to the previous year.
In 2023, SEC received 41 applications from sponsors for the initiation of clinical trials, compared to 25 in 2022. The main therapeutic areas in which clinical trials are conducted include oncology, allergology, neurology, cardiology, and dermatology. In total, as of the beginning of the year, 400 clinical trials have been registered in Ukraine—309 started and 91 approved by the Ministry of Health orders.
Among other positive trends in 2023 in the field of clinical trials are the resumption of clinical trials, the resumption of patient recruitment for clinical trials, the return of patients from abroad to approved clinical trial sites in Ukraine, the approval of new research sites (in Kyiv, Dnipro, Vinnytsia, Khmelnytsky, Zhytomyr, and Lviv), and an increase in the number of ethics committees.
"The life cycle of clinical trials conducted in Ukraine is supported by significant amendments to the research materials, which indicates the continuous compliance with Good Clinical Practice (GCP) requirements by the applicants. Moreover, the war has not stopped clinical audits - clinical audits are conducted at any stage of their conduct," states the SEC report.
The news was first published on the resource https://www.apteka.ua.
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