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  • Writer's pictureChristina DiArcangelo

INTERVIEW WITH ANNA TITKOVA, MD


Can you tell us about the current state of clinical research in Ukraine,

particularly in light of the ongoing conflict?


Picture of ANNA TITKOVA, MD

On February 24, 2022, when a full-scale invasion began, life in Ukraine came to a halt, including the clinical research industry, with about 600 active trials frozen and the majority closed prematurely. The State Expert Center of the Ministry of Health of Ukraine reported 132 letters of premature trial termination (108 due to the war and 24 due to financial, safety, and efficacy issues), along with 223 letters regarding patient transfer to other sites. Despite challenges, 63 trials started, 9 resumed, and 18 resumed patient enrollment during the reporting period.


What are some of the main challenges facing researchers and participants involved in clinical trials in Ukraine during times of war?

During wartime, patients and research teams face various challenges and risks, including internal migration, emigration abroad, mobilization, post-traumatic disorders, patient deaths, and site destruction due to hostilities, as well as restricted access to research centers. These threats have highlighted the issue of obtaining patient insurance for clinical trials, which has become one of the main barriers to initiating new trials in Ukraine.


How has the conflict affected the availability of resources and infrastructure needed for conducting clinical research in Ukraine?

In the initial 5-6 months following the onset of the war, Ukraine faced significant challenges in conducting clinical trials. Many medical institutions were damaged, leading to delays in drug and material delivery and insufficient customs clearance. Additionally, the blackout period presented new challenges related to maintaining the cold chain, ensuring internet connectivity, and safeguarding data. However, despite these obstacles, research centers persevered, adhering to protocols, freezing biosamples, conducting remote visits, and dispatching materials as needed.


What steps have been taken to ensure the safety and well-being of research participants and staff in conflict-affected areas?

Amid the ongoing crisis, each research center has autonomously determined measures to safeguard its staff and patients, considering factors like location, study volume, and patient availability. Our company prioritized employee support by providing full salaries for the initial 3 months of the conflict. Additionally, our clinic served as a refuge for employees displaced by rocket attacks, while 14 patients were relocated to our research centers in Poland for continued treatment. We maintained constant communication with all other patients, ensuring their participation in projects according to protocol completion over the course of more than a year.


Picture of  ANNA TITKOVA, MD

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 absolutely not optimistic. Right now, in the period of lack of stable access to medical care, lack of foreign medicines in pharmacies, Ukrainian patients need clinical research access even more than before. We should bring the message to Sponsors, 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 in the morning and stop their lives, but the example of Ukraine must show that in any circumstances 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.


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 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 that 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, we see the healthcare system, which is ready to participate in clinical trials with great enthusiasm and openness.


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 possible search for conscientious solutions, how we can help Ukrainian patients, medical professionals, 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.


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 from 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 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.


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 situation, how to continue the patient's participation in the study, and so on. But I believe that the main principle of our work - the patient's 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.


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 the good choice for conducting clinical research (large diverse patient pool and naive 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, 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 into Ukrainian future as Queen Elizabeth II once said: “The true measure of all our actions is how long the good in them lasts”.






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