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INTERVIEW WITH ANNA TITKOVA, MD
1. Can you tell us about the current state of Clinical Research in Ukraine, particularly in light of the ongoing conflict?
On February 24, 2022, with the start of a full-scale invasion, life inside Ukraine stopped, and with it, the Clinical Research industry also stopped. On the same day, all Clinical Trials were frozen (there were about 600 active ones) and then the majority of them were closed ahead of schedule. According to the official data of the State Expert Center of the Ministry of Health of Ukraine as the main regulator in the field of Clinical Research in the country in 2022 they received 132 letters of the premature termination of Clinical Trials in Ukraine (108 due to the war and 24 due to financial, safety, and efficacy issues) and 223 letters from Sponsors/CROs regarding the transfer of Patients to other Ukrainian or foreign Clinical Trial Sites, with the majority of oncological, neurological, rheumatological, gastroenterological, and cardiological Patients. But there are also some positive changes with 63 Trials starting, 9 resuming during the reporting period, and 18 Clinical Trials resuming enrollment of Patients.
2. What are some of the main challenges facing researchers and participants involved in Clinical Trials in Ukraine during times of war?
Wartime brings its challenges and risks for Patients and the research Teams such as migration inside the country and emigration abroad, mobilization, posttraumatic disorders, death of the Patient and the destruction of the Site as a result of active hostilities, restriction of opportunities to come to the Research Center. All these threats led to the issue of obtaining Patient insurance for Clinical Trials which is now one of the main reasons for the impossibility of starting the new Trials in Ukraine.
3. How has the conflict affected the availability of resources and infrastructure needed for conducting Clinical Research in Ukraine?
The first 5-6 months after the war started the country has limited possibilities to perform Clinical Trials normally. A lot of medical institutions were damaged, and the speed of delivery of drugs and materials, and customs clearance were not sufficient. Then the blackout period brought a new challenge with cold chain maintenance, internet connections, and data safety. But despite this, all Research Centers continued to work and carry out procedures according to the protocols, freeze biosamples, conduct remote visits and send materials.
4. What steps have been taken to ensure the safety and well-being of research participants and staff in conflict-affected areas?
In the current situation, each Research Center made independent decisions on how to protect its employees, and Patients, depending on the geographical location, the number of Studies, the availability of Patients on Site, etc. In our company, we paid full salaries during the first 3 months of the war to support employees financially, our Clinic became a home for employees who lost their homes in rocket attacks, and 14 Patients were transferred to our Research Centers in Poland for further treatment, with all other Patients we were constantly in touch, and after more than a year, I can say that all the Patients finished participating in the projects according to the protocols.
5. How do you see the situation in Ukraine affecting the future of Clinical Research in the country, and what steps can be taken to address these challenges?
Today, the outlook for the clinical trials industry in Ukraine is not optimistic. Right now, in the period of lack of stable access to medical care, and lack of foreign medicines in pharmacies, Ukrainian Patients need Clinical Research access even more than before. We should bring the message to Sponsors, and CROs that Ukraine is not the black spot on the world map of Clinical Research. We do not know what message, when, and where may wake up people at 4:45 am and stop their lives, but the example of Ukraine must show that in any circumstance there is always support from your community that will help to continue your dealings, will bring a sense of your activities and of life in general.
6. Are there any unique opportunities or advantages that come with conducting Clinical Research in a conflict zone or war-affected area?
As I said earlier, Clinical Research in a conflict zone or in times of war is becoming even more in demand and needed within society. For example, the Ministry of Health of Ukraine has implemented new shorter timelines for approval of Clinical Trials from 47 to 30 calendar days which should increase the attractiveness of our country for Sponsors. So, we see Patients who are interested in participating in Clinical Trials, we see research Teams that are ready to work quickly and efficiently, and we see the healthcare system, which is ready to participate in Clinical Trials with great enthusiasm and openness.
7. How can the international community support and collaborate with clinical researchers in Ukraine during this challenging time?
I believe that the international community should not forget about our country, we should be open to dialogue and possibly search for conscientious solutions, to how we can help Ukrainian Patients, medical professionals, and the economy of Ukraine at such a difficult time during such an unjust and difficult war. We should ask ourselves the question: are we flexible? Are we transparent? Are we fully committed to our mission in Clinical Trials? Now the whole world is passing the test on humanity, and what will be the result depends on everyone.
8. Can you speak to any specific Clinical Trials or research projects that are currently taking place in Ukraine and how they are being impacted by the conflict?
I may speak from the experience of our company. During this one-year period, our Clinical Research Site in Kharkiv (the city that is heavily bombed each day since the 24th of February) has finished 3 Clinical Trials with remote monitoring visits, on-site EOT visits, and full-fledged closed-out visits. Till February 2023 our Patients from 2 pulmonological Trials were able to receive their medication and be under medical supervision. 610 Patients in the COVID-19 vaccination Trial were under weekly telephone calls throughout the whole year and fully completed the study in March 2023. And now we successfully keep on performing a cardiovascular Trial with 56 participants that regularly visit our Site, receive IMP, and make all visit procedures according to the protocol.
9. Are there any specific ethical considerations that need to be taken into account when conducting Clinical Research in a conflict zone?
In general, the presence of war as an aggravating factor brings with it many ethical questions and prejudices about how to do the right thing, what to do in some situations, how to continue the Patients' participation in the study, and so on. But I believe that the main principle of our work – the Patients' access to innovative treatment and medical care – remains the main one both in peacetime and wartime, which we should be guided by in our work.
10. What do you see as the long-term implications of the conflict on the Clinical Research industry in Ukraine, and how can these challenges be addressed moving forward?
It is obvious that the Clinical Trial industry will be recovering for several years after the war finishes. But the reasons why Ukraine is still a good choice for conducting Clinical Research (large diverse Patient pool and naïve Patients as well, experienced, and highly qualified medical professionals, favorable regulatory conditions, competitive costs, etc) remain. To speed up this transition period Ukraine should improve its infrastructure and resources, make compliance with European regulations, and leverage existing expertise among the international community. And all of this is possible with the help of our international colleagues, with the understanding of our Patients' and medical professionals' needs, with the belief of Sponsors and CROs in the Ukrainian future as Queen Elizabeth II once said: “The true measure of all our actions is how long the good in them lasts”.
ABOUT ANNA TITKOVA, MD
Anna Titkova is an MD, Ph.D., MBA, and Professor
She is the Country Head of Ukraine's section of the intl. organization Pratia Ukraine
She is the director of Pratia Ukraine
Dr. Titkova graduated from and is currently teaching at Kharkiv National Medical University
She is the author of 150+ scientific publications and monographs
Dr. Titkova has 5 patented inventions
She is also an independent reviewer of scientific medical articles in the Ministry of Health of Ukraine journals
In March 2020, she opened the Pratia Ukraine LLC and the first SMO Clinical Research Site, Pratia Clinic Ukraine (under Pratia and Neuca)
The interview was published in The DiArc Magazine | An Exclusive Magazine by Christina DiArcangelo | June 2023
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