Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko, Clinical Research Director at Medical Center Ok!Clinic+ to understand the impact of the war and how the industry has been able to rebuild.
According to data analytics company Phesi, since the beginning of 2022 to October 1, the number of clinical trial recruiting sites in Ukraine has fallen from 1,814 to 940 (48%). Despite this drop, the remaining 52% are continuing to recruit in the face of obvious challenges due to the ongoing war.
Phesi’s data also shows that this trend can be seen across the regions affected by the conflict, as recruiting sites have fallen from 3,412 to 1,638 (52%) in Russia and from 84 to 33 (55%) in Belarus.
Russia invaded Ukraine on February 24, 2022. Access to medicines and healthcare has since been challenging in both countries. It was a subject of intense ethical debate whether life sciences companies should join other industries in leveraging sanctions against Russia, though many issued statements to say they had ceased clinical trial activity in the country. For more on the industry’s response to the conflict, read the DDW article ‘The Ukraine Conflict – The challenge for Pharma’.
“The drop in recruiting sites in Ukraine and in Russia sadly confirms our earlier prediction that the impact of war in the region on clinical development, and most importantly on patients, is considerable. However, what is heartening to see is that despite the terrible situation, there is still significant clinical trial activity taking place in the four countries that we have analysed,” commented Dr Gen Li, CEO and Founder, Phesi.
Ongoing clinical trials
Phesi’s original analysis issued in March 2022 highlighted that some indications under investigation in the region are set to be impacted more significantly. More than a quarter (26%) of all trials in schizophrenia take place in Ukraine and Russia, as well as a high proportion of gastrointestinal disease studies – including ulcerative colitis (14%) and Crohn’s disease (10%) (Figure 1).
There are clearly ethical issues associated with suddenly discontinuing treatment and wider medicine availability at a time of crisis, and it’s clear that trial sponsors and personnel have worked hard to maintain a high level of activity despite supply chain and security challenges.
The European Medicines Agency has issued guidance for sponsors of ongoing clinical trials affected by the war in Ukraine to help ensure the integrity of their studies and the interpretation of the study results, as well as the safety of trial participants.
One clinical research centre still recruiting for trials is Ok!Clinic+, based in the capital Kyiv, where fighting has been particularly severe since the start of the war.
Ok!Clinic+ staff are currently working on various ongoing clinical trials in 10 therapeutic areas in all I, II, III, IV Phases. The trials include investigations in cardiology (myocardial infarction, hypertension, ischaemic heart disease), rheumatology (RA, lupus, PsA, lupus nephritis, systemic scleroderma), gastroenterology (UC, Crohn’s disease, hepatitis, pancreatitis), endocrinology (diabetes, obesity), neurology (multiple sclerosis, epilepsy), haematology (leucosis, purpura, hemoglobinuria), oncology (lung cancer) and pulmonology (asthma, COPD, Covid-19 trials).
Early impact of the war
The invasion has obviously had a huge impact on patients, but also on supply chains, security and communication, all vital for successful clinical research outcomes. In the early days of the war, many Ok!Clinic+ patients (30%) were forced to evacuate and so could not continue with trials, though with support from neighbouring countries, some were transferred to other sites of the same study abroad.
Dr Olena Karpenko is Clinical Research Director at Ok!Clinic+. She explains how the centre responded to the initial invasion: “Our centre did not stop its work for more than a day, and all principal investigators, coordinators and nurses stayed in Kyiv. We quickly made the decision to use the capacity of a large local laboratory with which we are collaborating to monitor patient safety. We calculated the remaining investigational products, contacted all depots with a request to deliver all the drug in stock, and were also constantly in communication with representatives of contract research organisations (CROs) and sponsors.”
As the worst of the fighting moved to other parts of the country, patients were able to return home and continue treatment and after a while, the delivery of frozen biosamples, trial medicines and laboratory kits recommenced.
Despite this progress, Karpenko agrees with Phesi’s analysis that the impact has been severe: “Before the war, I received three to five new research proposals per week, but I have only had ten over the last eight months.”
Rebuilding the Ukrainian research sector
As clinical trials successfully resume, there is a sense of cautious optimism in the sector. According to GlobalData, 44 international clinical trials with a site in Ukraine have been initiated since the start of the war. Ok!Clinic+ has been able to start two new trials in the past few months, in ulcerative colitis and purpura, and reactivated studies in leucosis and Covid-19.
“Ukrainian researchers have passed a great test, which no civilised country in the 21st century can imagine. Today, practically nothing scares us, we work exclusively with the safety of our patients at the forefront,” Karpenko continues.
“It will take a long time to restore the previous activity of CROs and sponsors in Ukraine even if the war ends today, but we will regain our strength and capabilities and will be able to give much more to the world of clinical research. Our researchers’ main work is the study of innovative drugs for the treatment of socially significant diseases. Our mission is to provide patients with access to treatment with modern and effective drugs.”
The role of the international community
In contrast, no new international clinical trials have started in Russia since the start of the war, many trials have been terminated and companies have pulled out of their sponsorship1. This difference can most likely be attributed to the support the international community has shown to Ukraine, with many CROs and sponsors maintaining their work in the country despite having to put some trials on hold.
Neighbouring countries have played a particularly important role. According to Phesi, Poland has increased the number of recruiting investigator sites by 10% from 3,473 to 3,829, indicating that Poland has been able to fill some of the gaps in clinical development. In total across the four nations (Poland, Russia, Ukraine and Belarus), there are 2,578 sites still actively recruiting patients (Figure 1).
“It is encouraging to see that neighbouring countries like Poland have increased their own study activity. The main priority in clinical development should always be patient centricity, so maintaining as much research as possible is critical to patients in the region,” comments Dr Li. “The war in Ukraine is moving fast and disruption will continue for some time. I urge trial sponsors to keep up their vital work and continue funding sites, even those that might be suspended, and maintain dialogue with regulators and CROs to ensure data integrity is maintained.”
Karpenko echoes this sentiment. “We are grateful to every research centre that received and supported our patients in this difficult situation, despite the language barrier and administrative difficulties. We are also grateful to the sponsors for their assistance in the efficient transfer of our patients. What’s really important to us right now is the opportunity to be included in new trials. It will support the involvement of patients in their health, and will also greatly help the economy of Ukraine.”