One year has passed since Russia rolled its tanks into neighbouring Ukraine. The conflict accounts for the sobering toll of 7,199 killed and 11,756 injured civilians, according to the latest United Nations update.
The Russian invasion has had a dire effect on Ukraine’s healthcare system. A recent report by the non-profit organisation Physicians for Human Rights revealed that one in 10 of Ukraine’s hospitals have been directly damaged by the attacks, while one in three Ukrainians experienced lack of medical services. Clinical trial participants were also affected, as many had to flee dangerous areas and relocate either within or outside the country.
While the conflicts are mostly located in the eastern part of Ukraine, central and western areas strive to regain a sense of normality. Simultaneously, the Ukrainian clinical trial industry seems willing and ready to get back on track.
Once the war is over, the clinical trial activity in less affected areas might recover rather quickly, within 12–18 months, says Dr Vlad Bogin, CEO at Cromos Pharma, a US-based CRO with operations in Central and Eastern Europe.
However, the recovery path for Russia might be more complicated. Many companies have left the Russian market and economic sanctions have put many industries, including pharmaceuticals, on hold. Dr Vladimir Andrianov, former director of the Department of Clinical Trials at the First Moscow State Medical University, says that it might take a decade for international trials to come back to Russia. “Russia will recover only if there is a political resolution to [the war],” Bogin notes.
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Effects of the war on trials
According to GlobalData’s Clinical Trial Database, over 70 foreign-sponsored trials with a site in either Ukraine or Russia have been noted as disrupted by the war. Of these, almost half have sites in both countries. GlobalData is the parent company of Clinical Trials Arena.
The data shows that during the second half of the war, the number of affected trials in Ukraine decreased compared to the first half. In the first month of the war, no one was thinking about clinical trials because everyone was concerned about their personal safety, says Yuriy Lebed, CEO at Pharmaxi, a mid-sized CRO, operating in Ukraine, Poland, and other European countries. After several months, investigators decided to restart some of the trials but were faced with many logistical challenges, such as sample transportation.
Now, a lot of the services have been restored. Lebed explains that in its newly launched and ongoing trials, the company has no problems with investigational medicinal product (IMP) importation, laboratory, and logistical services.
Enrolled patients also had to adjust to the war, says Dr Regina Auškalnienė, head of clinical operations at Biomapas, a Lithuanian-headquartered CRO. She notes that 451 patients needed to be relocated from their homes; 172 were relocated inside of Ukraine and 279 moved to surrounding countries, 29 of whom have already come back to Ukraine.
In the meantime, affected foreign-sponsored trials with a site in Russia remained at similar levels in the first and second half of the war. While the clinical trial infrastructure is there, not many international sponsors want to go back, Bogin explains. “Even if you take away all of the ethical issues related to what is going on, you are still faced with logistical issues such as getting payments into the country and paying sites or investigators,” he adds.
Ukraine ready for new international trials
In August 2022, Clinical Trials Arena reported that the Ukrainian clinical trial sector is on the path to recovery. Yet, the data analysis shows that in the second half of the war, the number of multinational trial initiations decreased compared to the first half.
As the war still has no end in sight at this moment, international sponsors might be apprehensive to initiate trials in Ukraine, Bogin says. “If you can't get the data or monitor the sites actively, then all of this becomes an exercise in futility,” he adds.
While the Ukrainian research community is very driven and motivated to build back the clinical trial industry, Auškalnienė says that it will take time to convince international sponsors that it is safe to come back to Ukraine.
But questions related to patients, investigators, costs, and data integrity are only perceived risks and have already been addressed, says Dr Ivan Vyshnyvetskyy, president of the Ukrainian Association for Clinical Research.
Vyshnyvetskyy, who is also a managing director at FutureMeds, a Poland-headquartered independent site management organisation (SMO), says that some “brave” smaller biotech sponsors are coming back to Ukraine, while bigger companies are yet to make the step. “It was considered not too risky for Joe Biden to come to Kyiv, so why not international companies come here with their trials,” he notes.
Pharmaxi also recently launched three new clinical trials with international sponsors from Canada and Germany. “I hope this trend will be ongoing until the victory and then it will be a new age for Ukraine,” Lebed says.
Knock-on effect in Eastern Europe
Other Eastern European countries were also kept on their toes, as the war surged just next door. According to the Clinical Trials Arena data analysis, clinical trial activity measured as trial initiations decreased not only in Ukraine and Russia, but also in the surrounding countries like Poland, Czech Republic, and Hungary. However, the drop in initiations in other countries might not be directly linked to the war, but more as a by-product of economic challenges as some companies struggle with investments and funds, says Vyshnyvetskyy.
Bogin says that the region might recover in 2023, especially as many countries are compensating for the losses of sites in Ukraine. “The region is active like never before,” Auškalnienė notes. Many international sponsors have shown interest in Eastern Europe due to the low costs and abundance of patients who are willing to participate.
She explains that patients in Western Europe have better access to free medication. As a result, it might be hard to convince them to participate in a trial when there is a 50% chance they will receive a placebo. In some Eastern European countries, meanwhile, patients don’t have free access to some of the medications, so participation in a clinical trial means having at least a 50% chance to be treated.
Russia’s clinical sector in the gloom
At the beginning of the war, several big pharma companies pulled out of Russia to minimise their clinical trial footprint. As a result, it had negative effects on Russian patients, says Andrianov. For example, Bristol Myers Squibb completely ceased trials in Russia, some of which were oncology trials. He recollects talking to colleagues from oncology clinics and the challenges to find other appropriate therapies in a very short period of time.
Andrianov, who left Russia last year and is currently working for a Belgian CRO, says that while international sponsors had to react to the war, some of the decisions affected thousands of people, potentially even putting them at risk. “Did these people who suspended research think that the patients will overthrow the regime?” he questions. Yet other decisions, such as the suspension of Viagra supplies, are disappointing and “funny,” he adds.
If sponsors have moral and ethical obligations to Russian patients who were enrolled in their trials, they should provide them with top-edge approved treatments, Vyshnyvetskyy says. This way, they will still help patients without benefiting the Russian economy. “They will spend every dollar to renovate their tanks and build ammunition,” Lebed notes.
Based on public trial registry information, there is only a handful of foreign-sponsored trials registered after the war with a site in Russia that are planned to start in or after 2023.
While Roche’s Phase IV trial (NCT05208840) in leptomeningeal disease was registered in January 2022, the trial status changed from planned to suspended several times throughout the year. Johnson & Johnson’s Phase III oncology trial (NCT05714202) had a registered location in Russia on its EudraCT record when this article was published. However, in correspondence with this publication, the company confirmed that they have “suspended all advertising, enrolment in clinical trials, and any additional investment in Russia” in early March 2022.
Since ultimately the information that is publicly available in trial registries depends on the timeliness of updates provided by sponsors, Clinical Trials Arena reached out to them with the opportunity to comment on their planned trials listing a Russian location.
Auškalnienė agrees that there are ethical considerations to giving access to life-saving medication to any patient in the world, including Russians, but conducting international clinical trials in a country is a privilege, not a right. “Every sponsor should make that decision based on their internal values, but Ukrainians also have a right to life and safety,” she adds. Indeed, the suffering that Ukrainians see every day is not comparable in any way or form to potentially not having a novel drug, Bogin says.
If sponsors want to support Ukraine, Vyshnyvetskyy says that reviving the international trial sector is vital for the country. “This is the support we need today. We are not asking for charity; we want to work and exchange values,” he adds.
Additional data analysis by GlobalData senior analyst Priya Nair.
Note: After the publication of this article, a representative on behalf of Takeda reached out to Clinical Trials Arena to inform that the company will not have any sites in Russia for a Phase III ulcerative colitis trial. Originally, the company was included in the planned trial table as the trial registry (EudraCT-2021-000630-34) listed a Russian site. Takeda informed this publication that "they will be working to have the EU clinical trial registration site updated accordingly". The table was amended on 3 March.