| Ukrainian Clinical Trials –
Resilience, Efficiency, and Strategic Opportunity
|
Clinical trials in Ukraine –
resilience, efficiency and strategic opportunities
|
| Kyiv, September 12th, 2024 |
Kyiv, 12 September 2024 year |
| The Ukrainian Association for Clinical Research (UACR) and the State Expert Center of the Ministry of Health of Ukraine (SEC) jointly hosted a webinar showcasing Ukraine’s vibrant clinical trials landscape. |
Ukrainian Association of Clinical Research (UACR) and the State Expert Center of the Ministry of Health of Ukraine (SEC) jointly held a webinar devoted to the active development of the clinical research field in Ukraine. |
| The event highlighted how Ukraine continues to offer significant benefits for international sponsors, demonstrating resilience and adaptability in the face of ongoing geopolitical challenges. |
The event highlighted and emphasized how Ukraine continues to provide significant advantages for international sponsors, demonstrating resilience and adaptability amid current geopolitical challenges. |
| Key Takeaways for International Sponsors: |
Key takeaways for international sponsors: |
| 1. Thriving Clinical Trial Ecosystem:
As of April 2024, 290 clinical trials were active across various therapeutic areas in Ukraine, with oncology, gastroenterology, and rheumatology leading the field. Importantly, 75 new clinical trials were approved by Ukrainian regulatory authorities in 2023-2024 (through September), including studies from top sponsors such as AstraZeneca, MSD, Sanofi, Teva, and Janssen Pharmaceutica NV, as well as other middle and small-sized sponsors. |
1. Developed clinical trials ecosystem: As of April 2024, 290 active clinical trials were being conducted in Ukraine across various therapeutic areas, with leading positions in oncology, gastroenterology and rheumatology.
It is important to note that over 2023-2024 years (until September), Ukrainian regulatory authorities approved 75 new clinical trials, including projects from leading sponsors such as AstraZeneca, MSD, Sanofi, Teva and Janssen Pharmaceutica NV, as well as other medium and small sponsors. |
| 2. Efficient Regulatory Process:
The country offers faster study start-up times compared to many European countries, with regulatory review timelines reduced to 30 days for new trial applications and 25 days for substantial amendments. |
2. Efficient regulatory process:
Ukraine offers faster timelines for review of clinical trial materials for approval to start a study compared with many European countries.
The period of expert evaluation of study materials has been shortened to 30 calendar days for new applications to conduct studies and to 25 calendar days for substantial amendments (modifications) to clinical trials. |
| 3. Strong Recruitment and Top Enroller Status:
Ukraine consistently ranks as a topenrolling country in global trials, often exceeding recruitment targets. |
3. High efficiency of patient recruitment:
Ukraine consistently ranks among the leading countries by participant enrollment in global trials, often exceeding target indicators. |
| 4. Site Readiness and Operational Resilience:
Over 95% of surveyed sites report full operational capacity, with adequate investigational medicinal product supply and logistics for biosample shipments. Notably, 78% of sites are actively engaged in new trial feasibilities, showcasing their readiness for upcoming studies. |
4. Readiness of research centers and operational resilience:
More than 95% of the surveyed centers report full operational capacity, including adequate supply of investigational medicinal products and established logistics for shipping biosamples. Notably, 78% of centers are actively involved in assessing the feasibility of conducting new studies, demonstrating readiness for future projects. |
| 5. Mitigating Geopolitical Risks:
While acknowledging ongoing conflicts, particularly in eastern regions, the webinar emphasized that the majority of Ukraine’s research infrastructure in western and central regions remains fully operational. Sponsors are encouraged to focus on these low-risk areas to maximize trial success while mitigating potential challenges. |
5. Reducing geopolitical risks:
Recognizing the existence of military operations, especially in the eastern regions, the webinar placed particular emphasis on the fact that most of Ukraine's research infrastructure in the western and central regions remains fully functional. Sponsors are advised to focus on these low-risk regions for maximum research success. |
| 6. Experienced Workforce and Engaged Patients: Ukraine offers a pool of experienced investigators and research staff familiar with complex global trials.
The patient population is technologically savvy and eager to participate in clinical research, contributing to lower-than-average screen failure rates. |
6. Experienced personnel and motivation of interested patients:
Ukraine offers a pool of experienced investigators and research staff who have experience in complex global trials.
Patients are typically technologically advanced and adaptive to innovations in technology and are eager to participate in clinical trials, which contributes to a lower-than-average rate of clinical trial subject dropout at the screening stage – the "screen failure" rate is lower than the global one. |
| 7. Flexible Approaches to Ensure Continuity: Regulators and sites have embraced decentralized trial elements, including telemedicine visits, direct-to-patient drug shipments, and remote monitoring where necessary. This adaptability ensures trial continuity and data integrity despite geopolitical challenges. |
7. Flexible approaches to ensuring continuity:
Regulators and research centers have implemented elements of decentralized trials, including telemedicine visits, direct delivery of medicinal products to patients, and remote monitoring where necessary. This adaptability ensures continuity of research and data integrity despite geopolitical challenges. |
| 8. Cost-Effective Operations with High-Quality Data: While maintaining high standards, conducting trials in Ukraine can be more cost-effective compared to Western European countries. Sponsors consistently report high-quality data from Ukrainian sites, offering a compelling value proposition. |
8. Cost-effective operations with high-quality data:
while maintaining high standards, conducting trials in Ukraine can be more cost-effective compared to Western European countries. Sponsors consistently note the high quality of data from Ukrainian centers, which offers a compelling price-to-quality ratio. |
| The SEC and UACR remain committed to supporting clinical research in Ukraine, continuously working to enhance the regulatory framework and operational environment. |
The Center and the UACD remain committed to supporting clinical research in Ukraine, continuously working to improve the regulatory framework and operational environment. |
| Conclusion: |
In summary, we note: |
| A Strategic Destination for Global Clinical Trials Ukraine’s resilient clinical trial ecosystem, combined with regulatory efficiency, site readiness, and cost-effective operations, presents a compelling opportunity for international sponsors. |
Ukraine is a strategic location in the world for global clinical trials — the resilient clinical research ecosystem of Ukraine, combined with regulatory efficiency, the readiness of Ukrainian research centers and cost-effective operational procedures, presents a compellingly attractive opportunity for international sponsors. |
| The approval of 75 new clinical trials in less than two years, including studies from both industry leaders and smaller sponsors, underscores Ukraine’s continuing attractiveness as a clinical research destination. |
The approval of 75 new clinical trials in less than the past two years, including projects from both industry leaders and smaller sponsors, highlights the continued attractiveness of Ukraine as a location for conducting clinical trials. |
| By leveraging the country’s strengths in patient recruitment, data quality, and flexible trial designs, sponsors can accelerate their drug development timelines while benefiting from the unique advantages Ukraine offers. |
By leveraging Ukraine's strengths in patient recruitment, data quality and a flexible approach to trial design, sponsors can accelerate the timelines for development and market launch of medicinal products by taking advantage of the unique benefits that Ukraine offers. |
| Despite geopolitical challenges, Ukraine continues to demonstrate its ability to deliver high-quality, efficient clinical trials, making it a strategic choice for sponsors seeking to optimize their global research programs. |
Despite geopolitical challenges, Ukraine continues to demonstrate its ability to conduct high-quality and efficient clinical trials, making it a strategic choice for sponsors seeking to optimize their global research programs. |
