The Clinical Trials Subcommittee of the European Business Association (Global Business for Ukraine partner organization) for the second time during the full-scale war assessed the current state of clinical trials (CTs) in Ukraine and summarized the results of the industry’s work during martial law.
As a follow-up to the first CT assessment in Ukraine in June 2023, this analysis is mainly devoted to assessing further developments in clinical trials and updating information on the current state and trends observed in the industry.
During the full-scale war, the clinical trials industry was negatively affected, but gained unique experience and proved that it can reliably perform CTs even in difficult conditions. Despite all the challenges, the field of CT in Ukraine demonstrates resilience, adaptability, and high-quality research, which confirms Ukraine’s readiness to restore them.
If last year the Clinical Trials Subcommittee noted that new opportunities have appeared for the stable functioning of the industry during martial law, then today we see how these opportunities are being realized. In particular, in the first quarter of 2024, compared to the same period in 2023, there was an increase in the number of clinical trials submitted for expertise to the Ministry of Health/State Expert Center, as well as the number of approved and initiated clinical trials. In addition, there is a noticeable trend towards an increase in the number of approved CT sites compared to 2022-2023. The Annual Survey of Active CT Sites in 2024 also showed a consistently high level of adaptation to work, operational capacity, readiness for clinical trials, and willingness to participate in new trials. This shows the high resilience and flexibility of the industry in the face of challenges.
All participants of CTs in Ukraine continue to demonstrate a high level of reliability and quality of work, ensuring the safety of patients and the reliability of received data, applying their knowledge and experience, working in difficult conditions for the well-being of patients, and for the development of innovative medicines.
We are confident that further support and cooperation of all stakeholders will contribute to the sustainable development of clinical trials in Ukraine.
So, we welcome you to read the assessment!
The status of clinical trials in Ukraine is reflected in the following key indicators according to the data of the State Expert Center of the Ministry of Health of Ukraine (SEC and MoH) for 2022, 2023 and 1st half of 2024.
the total number of ongoing studies as of January 1, 2024 was 400 clinical trials, which is 49,6% less than in 2022, in particular, the number of initiated clinical trials was 47% less (as of the beginning of the relevant year);
There is a further trend towards the CTs recovery in Ukraine, despite the suspension and reduction in the number of CTs in the first year of the full-scale war rf against Ukraine, the experts of the CT Subcommittee see:
101 CTs were submitted for Regulatory Authority (RA) evaluation to the MoH/SEC after the full-scale invasion, and CTs were submitted 2,2 times more in Q1 2024 than in Q1 2023 (13 and 6, respectively);
75 CTs, submitted after the start of a full-scale war (May 2022 – 1H 2024), were approved for conduct (including 60 international multicenter CTs) at 349 CT sites, and 2 times more CTs were approved in Q1 2024 than in Q1 2023 (8 and 4, respectively);
83 CTs were started after the full-scale invasion (from Q2 2022), and 1,8 times more CTs were started in Q1 2024 than in Q1 2023 (14 and 8, respectively);
12 CTs were resumed;
in 31 active CTs patients’ enrollment was resumed;
in 2023-2024 there was no notification of the suspension of patients’ recruitment in the CTs;
46 patients returned from abroad to the CT sites in Ukraine;
181 new CT sites were approved with substantial amendments to 57 active CTs conducted by 36 sponsors (including 33 international companies), the geographical distribution of which is shown in the diagram. At the same time, in 2024 there is a tendency to increase the number of approved CTs sites compared to 2022-2023.
The regulatory authorities (RA), namely the MoH and SEC, steadily continue to evaluate and approve CT materials, and perform regulatory supervision of CTs in Ukraine.
The SEC continues to conduct RA clinical audits (scheduled and unscheduled), including the compliance with regulatory requirements when transferring subjects to other CT sites during the war. It should be noted that the annual number of RA clinical audits in 2024 (including those planned for the second half of 2024) coincides with the level of 2021, despite the reduced number of current clinical trials. Conducting RA audits is an important aspect of guaranteeing the quality of CTs and protection of the rights, safety and well-being of patients participating in CTs.
Training seminars are held as usual in accordance with the SEC schedule, in particular on compliance with the principles of Good Clinical Practice (GCP), including under martial law. In 2022 – the 1st half of 2024, the SEC conducted 24 GCP trainings, which were attended by 1335 trainees (researchers, applicants’ representatives, members of ethics commissions, etc.).
Local Ethics Commissions have adapted to the current conditions, including the use of remote access technologies and the transition to electronic document management based on the SEC recommendations (the updated SEC list includes 390 local ethics commissions).
CT sites continue to be fully operational in the current active CTs and in new CTs that are starting.
The Annual Survey of operating CT sites conducted by Association CT Subcommittee, in which 121 CT sites participated, showed that in 2024 the following indicators remain at a high level: the adaptation of CT sites to work (100%), the ability of the CT sites to work in the current environment (97%), the operational capacity of the CT sites (99%), the standard work schedule (99%), the readiness of the CT sites to conduct CTs (98%) and the willingness to participate (~100%).
Logistical support has improved – none of the CT sites have reported inadequate logistical support to CTs, including transportation of bio samples.
It is also important to note that a larger number of CT sites reported:
increasing feasibility (78% vs. 64% in 2023) and
preparation for the start of CTs at the CT sites (53% vs. 37% in 2023).
The patients visit hospitals within the framework of active CTs. Thus, 80% of the surveyed CT sites in 2023 and 94% surveyed CT sites in 2024 confirmed that the number of patients in their sites has increased or remained at the same level.
Logistics support of CTs. Experts of the Association CT Subcommittee note that the logistics chains and all the main local depots are working in full. All deliveries of CT materials and equipment for clinical trials (export, import) take place in standard mode using land transport. Land transport is also used to export bio samples.
CT monitoring is carried out through remote monitoring and visits to the CT sites depending on the restrictions imposed by companies. According to the CT sites survey, 94% of respondents indicated that there are no restrictions on monitoring visits from the CT sites, and only 3% reported some restrictions.
CT sites audits conducted by sponsors/Contract Research Organizations (CROs). According to the member companies of Association CT Subcommittee, the audits were conducted both online (31%) and offline (19%) with visits to the CT sites. Almost half of the companies (44%) said they plan to conduct audits this year (31% – remotely and 13% – with visits to the CT sites).
During this time, significant steps have also been taken by all stakeholders to improve the regulation of СTs and the conditions for CTs conducting in Ukraine.
The mechanism for ensuring the continuation of treatment of patients with an investigational medicinal product (IMP) outside the clinical trial through the programs of access of CT subjects (patients) to the IMP after the CT completion (PTTA), as well as the programs of expanded patient access to unregistered medicines (CUP) has been actively implemented. The MoH approved 7 programs for access of CT subjects to the IMPs after CTs completion with the participation of 117 patients and 27 CT sites as of the date of formation of this letter for the period from May 24, 2023. It is important to note that in 2024, the reduction of VAT on the import of medicines in such programs from 20% to 7% was legislated.
The requirements for insurance in the CTs were regulated.
The announced shortening of the general terms for CTs approval, primarily due to the reduction of the term of evaluation of CT materials to 30 days, is being implemented in practice, and the member companies of the Association CT Subcommittee note the observance of these deadlines by regulatory authorities.
Active work continues on the further harmonization of Ukrainian legislation with European requirements. According to the information of the member companies of CT Subcommittee of the Association, it is planned to accelerate the enactment of the new Law of Ukraine “On Medicinal Products” No. 2469-IX dated July 28, 2022, which will significantly improve the regulatory environment for conducting CTs in Ukraine.
It is also expected that the acceleration of the start of work in Ukraine the new single regulatory body (State Control Body), which implements state policy in the field of creation, admission to the market, quality control, safety and efficacy of medicines, should improve and optimize the regulatory support of CTs.
According to the experts of the Clinical Trials Subcommittee, all CTs stakeholders have demonstrated a high level of reliability of work in CTs ensuring the safety of patients and the reliability of the data obtained in the new conditions of conducting CTs in Ukraine, the ability to effectively cooperate between the regulator, business and clinical sites and quickly adapt to the new reality. CT sites have confirmed their readiness and ability to participate in new CTs. Active work to further improve the regulatory environment for CTs in Ukraine is in progress. There is a trend towards an increase in the number of approved CTs in Ukraine and approval of new CT sites in active CTs.
Despite the war, the most favorable conditions have been created for the rapid recovery of CTs in Ukraine right now, to restore and increase Ukraine’s contribution to the development of innovative medicines in the world.
In case of any questions, please feel free to ask – Iryna Magdik, EBA Clinical Trials Subcommittee Executive Director Iryna.Magdik@eba.com.ua
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