As Russia’s clinical trials sector falls, Ukraine rebuilds

August 24 marks six months since the start of Russia’s war in Ukraine. A United Nations update on August 15 reports that approximately 5,514 civilians have died and 7,698 people have been injured, with the actual figures likely to be considerably higher. The war is still doing huge damage to the economies of both countries due to the military invasion in Ukraine and companies pulling out of Russia. 

Focusing on the clinical trials landscape, as of August 18, 28 foreign-sponsored, multi-country studies were publicly acknowledged by sponsors as being impacted by the war, according to GlobalData’s Clinical Trials Database. Of these, almost half have sites in both Ukraine and Russia. That said, the war’s ripple effects are likely to be far reaching. GlobalData is the parent company of Pharmaceutical Technology Focus.

Fast forward to six months after the start of the war, the clinical trials sectors of both countries appear to be on different paths. Ukrainian Association for Clinical Research president Dr Ivan Vyshnyvetskyy says Ukraine’s local activity is on the journey to recovery. In fact, several studies are back to recruiting participants locally, and new studies have been initiating in the past several months, he adds.

In Russia, it’s a different story. Dr Vladimir Andrianov recently left his position at the First Moscow State Medical University as the director of its Department of Clinical Trials. Andrianov also left Russia earlier this month. “The clinical trials industry in Russia is dead.”

When the Ukraine war started, clinical trial activity in the country was frozen, Vyshnyvetskyy recollects. While some overseas-sponsored studies with recruited patients managed to continue, investigations with a small number of participants or ones that are yet to recruit had local sites scrapped or put on hold, he adds. “Nobody knew what to do next because players did not know when the full-scale aggression would stop.” 

The war has impacted clinical trials in different ways. Non-Ukraine sites in multinational studies may have had to recruit more participants to compensate for Ukraine sites closing, says Dr Regina Auškalnienė, chief global clinical research officer at Lithuania-headquartered CRO Biomapas. 

As another consequence, patients might have been dropped from non-critical studies to prioritise the safety of Ukrainian trial participants, Auškalnienė adds. This means that they would have been replaced by participants from sites in neighbouring countries, she says. There is the option of adding more non-Ukraine sites and countries in the study, but it can be costly. 

GlobalData’s database shows there are 22 foreign-sponsored, multi-country clinical trials with a site in Ukraine that are disrupted or potentially disrupted by the war. Out of these studies, 19 are still listed as ongoing. For context, there are 678 ongoing foreign-sponsored, multi-country clinical trials listed with at least one site in Ukraine. 

Of the 22 studies, 12 are in Phase III, eight are in Phase II, and two are in Phase II/III. Six of these studies are in infectious disease, and there are three trials each in central nervous system, oncology, and respiratory disease.

After months of hard work, there is now a sense of returning to normalcy in Ukraine-based study sites. New trials have started locally in the past several weeks, Vyshnyvetskyy notes. In the past six months, two single-country studies were initiated, as well as 44 multinational investigations with a site in Ukraine, according to GlobalData’s clinical trials intelligence.

While clinical trial logistics was a big issue earlier in the year, there are now alternative routes. Ukraine’s airspace is still closed, but in the past several months, CROs and sponsors invested the time needed to figure out how to analyse samples locally, Vyshnyvetskyy says. Materials can also be transported by land to Poland, where samples are then flown to various destinations, he adds. 

Still, Ukraine’s path to recovery should not be overstated. There are still logistical challenges—it is a case of Ukraine adjusting to a new reality, Auškalnienė explains. 

As many as 100 patients were moved to neighbouring countries earlier this year, Vyshnyvetskyy notes. However, a notable number of these patients have since relocated back to Ukraine, he adds. It is more typical for study participants to be moved to safer parts of the country.  

Overseas sponsors and CROs have accepted the risk and cost of keeping clinical trials going in the country, Vyshnyvetskyy notes, adding these companies have done so in support of Ukraine. A Labcorp spokesperson says that while the CRO is not actively pursuing new work in Ukraine, it is prepared to support sponsors if they choose to begin new studies there. A top priority is the safety of its employees and patients recruited in both Ukraine and Russia, the spokesperson adds.

Meanwhile, in Russia, there have been no new, international, multicenter clinical trials with sites in the country since the war in Ukraine started, Andrianov says. Before the invasion, First Moscow State Medical University, also known as Sechenovskiy Universitet, was one of the biggest universities in Russia and host to as many as 120 ongoing clinical trials. 

In H1 2022, Russia’s local regulatory body approved as many as 111 international clinical trials to open sites in the country, Auškalnienė notes. However, a vast majority of these studies is unlikely to open sites there. Even if overseas sponsors want to keep ongoing studies active in Russia, it is “near impossible” to do so due to logistical and operational issues, she notes. 

While there are still ongoing clinical trials, these are by local sponsors, which do not compensate for the gap left by international studies, Andrianov adds.

The ongoing trials in Russia are mainly bioequivalence studies recruiting healthy participants, Andrianov notes. Recruitment is likely to be slower, especially for larger trials, he says. If samples need to be sent overseas, such as in Turkey or the Persian Gulf countries, the journey takes twice as long and is more expensive. There are 146 Phase I pharmacokinetic (PK) and pharmacodynamic (PD) studies ongoing or planned in Russia with a start date on or after February 24.

GlobalData’s trials database also reveals that there are 16 foreign-sponsored, multi-country studies with a site in Russia that have been specifically noted by the sponsor as disrupted or potentially disrupted by the war. Of these 16 trials, 13 are in Phase III, two are in Phase II, and one is in Phase II/III. These studies cover multiple indications, with three trials each in oncology, infectious disease, and hormonal disorders. 

There are 1,188 ongoing, foreign-sponsored, multi-country trials listed as having a site in Russia. However, the reality is that many international pharmaceutical companies have publicly announced they were exiting the country. 

Bristol Myers Squibb (BMS) is on the more extreme end of the spectrum, completely severing its ties to Russia. News reports show that it started to hand over its local operations to its Russian distribution partner Swixx Healthcare on May 18. Andrianov says BMS pulling out elicited an emotional response from patients and clinicians, with the company having had several trials with around 2,000 patients in the country. BMS did not respond to a comment request. 

Patients in international trials with discontinued local sites are likely to have been shifted to other studies or integrated to government-sponsored programmes, Andrianov says. Clinical trial staff that are employed by international firms face uncertainty, he notes, adding that among staff working for Russian companies, there is more stability but “they are a bit nervous”. 

Dana Leff Niedzielska, co-founder and CEO of the CRO August Research, says parts of the sector are unlikely to discount Russia as a potential clinical trial destination in the future due to the country having a deep pool of patients. However, as it stands, it is hard to know when, how, or if this is possible, she adds.

A total of 23 sponsors revealed that the war would affect their respective multi-country trials. The database shows that four out of 28 impacted trials are terminated, with 24 studies still listed as ongoing. Intra-Cellular Therapies has had four trials affected, while Camurus and Vicore Pharma have two studies each. 

Intra-Cellular has announced that three separate Phase III lumateperone tosylate trials (NCT05061706, NCT04985942, and NCT05061719) for major depressive disorder have been affected. The fourth Phase III study (NCT04285515) is recruiting bipolar depression and major depressive disorder patients. Camurus has two different Phase III octreotide trials (NCT04125836, NCT04076462) in acromegaly, with both studies having sites in Russia. 

Vicore Pharma’s two studies testing VP-01 were disrupted: one Phase II/III trial in Covid-19 (NCT04880642) and a Phase II idiopathic pulmonary fibrosis trial (NCT04533022). Both Intra-Cellular Therapies and Vicore have sites in both Russia and Ukraine, with the companies separately indicating that enrolment and recruitment could be impacted by the war. These three companies did not respond to a comment request. 

Since the war started, GlobalData has been monitoring and tracking both disrupted and potentially disrupted clinical trials. Information from GlobalData’s clinical trials database is sourced from over 140 clinical trial registries worldwide, alongside clinical research publications, over 200 scientific conferences, press releases, company websites, and company filings, among others.

Back in Ukraine, Vyshnyvetskyy is optimistic. The challenge now is to prove that Ukraine is still a reliable place to conduct clinical trials, specifically in the western part of the country, he says. There have been regulatory moves to expedite the approval process in initiating studies, he adds.

Despite the Covid-19 pandemic paving the way for remote monitoring to be a standard part of trials, some study elements still require onsite visits, he explains. 

Most importantly, Dr Oleksii Korzh, Department of General Practice head at Kharkiv Medical Academy of Postgraduate Education, says the ultimate challenge is to ensure the safety of patients and investigators. Korzh and Vyshnyvetskyy agree that it is imperative for Ukraine to remain as an attractive host to trials, with Vyshnyvetskyy explaining that it is going to be a key foundation to the country’s healthcare and economic rebuild. “We can demonstrate resilience.” 

Additional data analysis by GlobalData senior analyst Priya Nair.

Main image credit: Getty Images/ArtemisDiana