“Medication” by Gatis Gribusts, CC BY 2.0
Clinical trials are needed in Ukraine, so we can protect our professionals and patients, help advance medical science and improve regulation and ethical standards across the board.
Dr Ivan Vyshnyvetskyy is the managing director of FutureMeds and President of the Ukrainian Association for Clinical Research
In the clinical research setting, Ukraine has been able to provide aligned regulatory processes, resilient medical infrastructure, highly educated practitioners, low-cost trial structure, high recruitment rates, and quality data confirmed by numerous FDA (US Food and Drug Administration) and EMA (European Medicines Agencies) audits.
Yet ever since the war started, our excellent clinical trials infrastructure is suffering considerably. As new studies are moved to alternative countries, clinical research in Ukraine is losing experienced clinical research professionals who have the ability, networks, know-how and drive to foster clinical development as well as strengthen local research capacity. In this news blog, I want to argue why it might be ethical to conduct studies in Ukraine despite the war.
Ukraine, a resilient clinical trial destination
We, as a country, have been in a state of war for almost a decade now. I, for example, have been working as a clinical trial investigator in Donetsk when fighter jets were flying in 2014.
Overnight, the war cut off the established transportation and logistical routes to Donetsk. Yet despite the growing terror, we health care professionals and researchers continued to look after our patients. We transferred some of them from high-risk locations to low-risk places and found ways to protect study materials and sponsors’ data.
The situation we found ourselves in was unexpected at the time, but we managed to adjust. In fact, these last 9 years of conflict made our health infrastructure and our professionals more resilient and resourceful. Ukraine was considered an attractive destination despite the war in the East, and the number of new clinical trials in the country increased 2.5 times during the last 5 years.
Simultaneously Ukrainian healthcare systems continue to demonstrate resilience. The recently introduced centralised electronic health system which already has more than 500 million electronic medical records, successfully overcame all war-related challenges. All our hospitals, which are considered critical infrastructure, have their own power sources and stable internet connections. As a result of the collective effort of all stakeholders, the majority of research sites that are not in the occupied or adjacent territories continue their job as usual in ongoing trials:
- Sites have all systems and capabilities in place to produce high-quality data.
- Studies are monitored (on-site and remotely) by CRAs (Clinical Research Associate or Trial Monitor) and inspected by Regulatory Authorities.
- Samples are shipped to neighbouring counties by land and later via air to distant destinations
“Research“, CC BY 4.0
A large patient population without access to new clinical developments
Ukraine’s large population presents CROs (Clinical Research Organisations) and Sponsors with a large untapped patient pool for clinical trials, which can be particularly advantageous for trials involving rare diseases or conditions where it can be difficult to recruit enough participants. Yet, the benefits of running clinical trials are also considerable for Ukraine, especially now.
The war has had devastating economic consequences. The baseline prediction from the World Bank and United Nations Development Programme was that Ukraine’s poverty rate would rise more than 10 times and reach up to 90%.
According to pre-war estimates, commercial clinical trials annually contributed to the Ukrainian economy by about 500 million USD, created about 5,000 jobs and gave over 30,000 patients free access to high-quality medical care, which is not always available in the general health system. And today all these benefits are almost completely lost because international sponsors are hesitating to start new studies in Ukraine.
We believe that giving back Ukrainian patients access to clinical research will allow us to fulfil several requirements stipulated in ethical guidelines:
- Provide appropriate access to participation in research to groups that are underrepresented in medical research (WMA Declaration of Helsinki, article 13)
- Sponsors and researchers … must make every effort, … to assist in building local research capacity. In some cases, … investments in the local health infrastructure should be provided to the population or community (International Ethical Guidelines for Health-related Research Involving Humans, Guideline 2)
- Researchers and sponsors who plan to conduct research in these communities should contribute to capacity-building for research and review. (International Ethical Guidelines for Health-related Research Involving Humans, Guideline 8)
With new studies starting in our country, we can protect our patients and research professionals, continue to improve and align regulations and increase ethical standards, and contribute to advancing medical science.
Talk to your CRO and Sponsor contacts and spread our message
We understand and appreciate why some Sponsors and CROs might consider Ukraine a high-risk country, and in their shoes, we might feel the same. More often than not, due to the lack of firsthand information and accurate reports from our country, the risks might be overestimated.
That’s why it is important to highlight the realities of our clinical trial setting and the collective progress we made throughout the last decade, which was effectively in war. Since last February, we in Ukraine have worked tirelessly to overcome logistical, system and safety challenges.
If you are working for a sponsor or CRO, or have professional associates who work there, spread our message. Your sharing of this message can help us get the studies we need to protect our professionals and patients and to advance medical science.
About the Author
Ivan Vyshnyvetskyy, MD, PhD, Managing Director, Ukraine, FutureMeds
Ivan is on a mission to help protect and develop clinical research in Ukraine. As the President of the Ukrainian Association for Clinical Research, he aims to increase cooperation with the Ukrainian regulatory body, harmonise legislation, protect the rights of research doctors, patients and improve clinical trial awareness among patient populations.
With over 20 years of experience conducting clinical trials as a physician-investigator, Ivan has a thorough understanding of the clinical trial challenges of Ukraine. He participated in over 70 clinical trials in various indications, including over 50 as Principal Investigator.
He graduated from Donetsk National Medical University (Ukraine), where he gained a PhD in Cardiology and an Associate Professorship in Internal Medicine.
In November 2021, Ivan joined FutureMeds, a fast-growing professional clinical research site network, as Managing Director of FutureMeds Ukraine.