Decentralized clinical trials in Ukraine – this was discussed at a meeting between the management and experts of the Center and representatives of the Chamber of Commerce and Industry of Ukraine (CCI).
On behalf of the State Expert Center of the Ministry of Health of Ukraine, the discussion was attended by Director Mykhailo Babenko, Deputy Director for Clinical Issues Mykhailo Lobas, Director of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials Taisa Herasymchuk (online), Head of the Directorate for Audit of Laboratory and Clinical Practice (GLP, GCP) Serhii Rasputniak, and Head of the Clinical Audit Division for Clinical Studies Lesia Yankova.
During the meeting, the parties discussed:
- experience of conducting decentralized clinical trials in EU countries;
- regulatory norms for conducting combined CTs in Ukraine (traditional clinical trials with decentralized elements);
- possibilities for logistical support of combined studies.
- expanding the possibilities for conducting combined clinical trials in Ukraine.
Mykhailo Babenko thanked the representatives of the Chamber of Commerce and Industry for initiating the meeting and for helping to attract sponsors and clinical trial operator companies to Ukraine.
According to him, Ukraine is interested in an increase in the number of clinical trials and in the development of their innovative and scientific-medical technologies. “Taking into account the recommendations of the European Commission and the EMA, we are ready to support the development of clinical trials with decentralized elements at the national level and to expand cooperation with interested sponsors. Our main task in doing so is to strictly comply with the relevant legislation governing the conduct of clinical trials in Ukraine and with ethical principles, taking into account the safety, rights, and well-being of trial subjects,” the Director of the Center emphasized.
The use of decentralized elements in the clinical trial system in Ukraine is possible, but it must be substantiated in all materials and documents accompanying the study. This was emphasized by Taisa Herasymchuk, Director of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials. She was also supported by colleagues responsible for conducting clinical audits of CTs. Clinical trials with decentralized elements must take into account not only convenience for patients but also their safety, and must comply with the requirements of the current legislation of Ukraine, international standards and recommendations.
Summing up the meeting, the Center's Deputy Director for Clinical Affairs Mykhailo Lobas assured participants of the Center's readiness to consider the proposals of interested sponsors and to provide all necessary expert consultations.
The use of hybrid clinical trials with properly justified decentralized elements can make it easier for patients to participate in clinical trials, which is extremely relevant in conditions of war, pandemics, destruction of hospital infrastructure, and logistical disruptions.
For information, decentralized clinical trials are a common technology worldwide. Today this format is hybrid, that is, it includes the traditional format – a trial site – with the use of decentralized elements, which may relate to patient visits to trial centers, adjustment of the informed consent process, distribution of the investigational medicinal product, data management and monitoring under specific circumstances, trial-related procedures at home, etc. The use of decentralized elements in clinical trials depends on many factors, including (but not limited to) the type of clinical trial, the study population, the disease being treated, the condition of the trial participant, the type of medicinal product, its characteristics and stage of development, etc.
