What can you tell us about the Pratia site network?
Pratia is an international site network. We are operating in seven European countries and, beginning this year, in the United States. I’m the country head of Pratia Ukraine and the director of international operations, focused on operational efficiency and excellence in performance and recruitment.
We have two different models: one is our own clinical research sites that are fully engaged in clinical trials, and the other is embedded/dedicated clinical research units within medical institutions. We have a strong focus on oncology in Poland, Ukraine, Spain and Bulgaria, and we’re expanding that to Germany and the Czech Republic. We had a strong presence in infectious disease studies during 2020-2022. In Poland, we have a large Phase I/first-in-human unit.
In Ukraine, we have our own clinical research site and seven units embedded in Ukrainian hospitals.
"We have a huge demand from our patient population for innovative treatments, particularly when there is a lack of supply of simple medication or the typical healthcare infrastructure stability."
What have been the challenges you’ve faced in running clinical trials at Ukrainian sites?
Ensuring a safe environment for trials is the major obstacle, as is the destruction of healthcare infrastructure.
Particularly in the beginning of the conflict, there were challenges accessing essential medications, shipment of drugs, the staff required, and it was a problem to even receive standard-of-care medications in Ukraine. There were struggles with data collection and monitoring, especially in the first few months.
We’ve had some difficulties with patient enrollment and retention due to the displacement of people, the emotional and physical stress, and the restricted access to healthcare facilities.
How have those been solved/addressed?
In terms of physical damage, we have seen that a lot of the damages received quick repairs and feedback from the authorities and from sponsors to help ensure that there aren’t any supply-chain interruptions or power outages. We have since gathered the necessary resources and backup – electricity, internet, electronic medical sources, storage, etc. – to allow for remote monitoring.
There are some regulatory and ethical complexities, particularly regarding informed consent, data integrity and participant wellbeing, requiring adaptive strategies from our researchers, but those have been covered by regulatory authorities, our local ethical committees and research teams.
What has clinical research meant to people in Ukraine?
We have a huge demand from our patient population for innovative treatments, particularly when there is a lack of supply of simple medication or the typical healthcare infrastructure stability to perform an MRI, for example.
Clinical research is the way that they can continue to receive care and have a better quality of life. From my experience the last few years performing clinical research in Ukraine, our patients are more motivated to participate than before.
What expectations should industry sponsors have about trial performance for sites in Ukraine?
Industry sponsors should be aware that Ukrainian research sites have demonstrated extraordinary resilience and commitment to maintaining clinical trials. Because they are facing these immense challenges, there should be flexibility, understanding, support and key considerations to account for this human and emotional toll, more time spent on communication around logistics and infrastructure. Many of the people working on our sites have lost colleagues or family members but are still continuing their work.
I would encourage industry sponsors to provide encouragement, some mental health support and realistic expectations around workload, as well as open communication with the people who are living in these unpredictable circumstances.
Is there anything that sponsors could do that would be helpful during this time?
It would be helpful for sponsors to consider implementing decentralized clinical components, flexible visits or adaptations of protocol, because we’ve had some transportation difficulties and safety concerns that made patient enrollment and retention significantly more difficult.
That would, for example, allow research staff to do these remote activities, go to patients' homes, mitigate supply-chain risks, etc., to ensure the stability of clinical trial performance. That stability motivates patients to come to a research site and participate.
"Ukrainian research sites have demonstrated extraordinary resilience and commitment to maintaining clinical trials."
What help would be beneficial to you that is reasonable/feasible from the sponsor perspective?
We just need to be on the map of clinical researchers. We just need to be given the trials, and we can perform them. Over the past three years, we’ve become very adaptive to all the changes that have occurred, and we’ve actually seen that, in terms of patient engagement and enrollment, we are equal to other sites in the world.
Ukrainian sites need to know that they are still part of the international research community. Our patients need to know that they still have the possibility of participating in life-saving treatments.
Tell us the story of how you enabled a patient to continue participating in a clinical trial.
During the beginning months of the war, we were trying to transfer patients from Ukraine to other countries, particularly Poland, to continue their clinical trial participation. One patient was a young woman in Kharkiv, Ukraine with advanced Hodgkin’s lymphoma. She had been diagnosed in March 2020, passed all available treatment options on a market without positive outcome, and was enrolled in a pembrolizumab clinical trial as the last survival chance. After two doses of pembrolizumab, we saw significant disease regression and her condition improved significantly.
However, when the war started in February 2022, she was told that it was impossible to continue the trial because all IMP shipments to Ukraine were stopped. We worked intensively with her doctors, site representatives, Polish and Ukrainian regulatory authorities, etc., to be able to transfer her to a Polish clinical trial site appropriately without her dropping out of the trial.
We had to do this quite quickly, because it needed to be done before her next infusion. If we had missed her next infusion, she wouldn’t have been able to continue participating in the trial, regardless of where she was. So, within a few weeks, she was transferred and received her next dose. She’s still a participant in the trial and she’s in stable condition.
Why is it important for people to know that story?
Sometimes in clinical research, we’re so focused on KPIs and other numbers that we don’t remember how a clinical trial could change a patient’s life. But for our patients, it’s so much more than that. So, if we want to be truly patient-centric, it means putting patients first, and this was an example of that. This patient was a partner to us. She put her trust in us, enough to leave her family in Ukraine and move to Poland alone to continue receiving treatment.
We’ve been able to move 14 patients in different trials to Poland in order to continue participation in clinical trials. Some patients have even returned to Ukraine, to their previous clinical sites, to continue treatment.
It is our duty to not only to perform clinical trials according to GCP, but also to bring them to people who need them more than ever. I don’t want Ukraine to be a black spot on the map of clinical research. This place requires our attention, participation and contributions to help patients receive support and assistance.
"Sometimes in clinical research, we’re so focused on KPIs and other numbers that we don’t remember how a clinical trial could change a patient’s life. But for our patients, it’s so much more than that."
What would be your message to industry sponsors?
Despite the challenges, Ukrainian research sites remain highly capable and motivated. We have adapted quickly, embraced innovation and upheld scientific integrity, even in the face of adversity. Sponsors should view this as an opportunity to strengthen long-term partnerships, to invest in research infrastructure, and to support the recovery of Ukraine’s scientific community.
Industry sponsors can help sustain vital research efforts and ensure life-saving trials continue, despite the challenges of war, by acknowledging the on-the-ground realities and working collaboratively with Ukrainian sites.
We understand that the business and financial sides of clinical research are very important, but these are also incredibly important for patients. While there may be financial challenges or risks, patients everywhere should have equal access to the same innovative medicine and the possibility to participate in clinical trials.
