CLINICAL OPERATIONS AND OUTSOURCING
GlobalData’s database shows that there are 22 foreign-sponsored, multi-country trials with a site in Ukraine that have been 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.
Sector recovering amid Ukraine war After months of hard work, there is now a sense of a return to normalcy in Ukraine-based study sites. New trials have started locally in recent 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 database. 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, contract research organisations (CROs) and sponsors invested 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 Earlier this year, as many as 100 patients were moved to neighbouring countries, 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 says, 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.
Russian trials space shrinks Meanwhile, in Russia, there have been no new, international, multi-centre clinical trials with sites in the country since the war in Ukraine started, Andrianov says. Before the Russian invasion, First Moscow State Medical University, also known as Sechenovskiy Universitet, was one of the biggest universities in Russia and host to up to 120 ongoing clinical trials. In H1 2022, Russia’s local regulatory body
approved as many as 111 international clinical says. However, a vast majority of these studies are 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 and do not compensate for the gap left by international studies, Andrianov adds. “It’s like when McDonald’s left Russia – the menu might be the same, but it has a different taste.” The ongoing trials in Russia are mainly bioequivalence studies recruiting healthy participants, says Andrianov. Recruitment is likely to be slower, especially for larger trials, he adds. If samples need to be sent overseas, such as to 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 2024.
The exodus from Russia GlobalData’s trials database also reveals that there are 16 foreign-sponsored, multi-country studies with a site in Russia that have been or “potentially disrupted” by the ongoing conflict. 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 also 1,188 ongoing, foreign-
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