Trial disruptions due to the Russian invasion of Ukraine

The turmoil surrounding Russia and Ukraine has had an impact on the pharmaceutical industry in both regions. It is becoming more prevalent that clinical trials with a location in Russia or Ukraine are being disrupted, and if those trials are multinational, the disruption can create a ripple effect.

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According to GlobalData’s Clinical Trials Database, eight trials have so far been disrupted and another eight may be impacted by the Russian invasion of Ukraine. Of the disrupted trials, six are in Phase III and two are in Phase II. One study that has already been disrupted is by Aridis Pharmaceuticals, investigating AR-301 (KBSA301) as an adjunctive therapy to antibiotics for the treatment of Staphylococcus aureus ventilator-associated pneumonia. According to the sponsor, the Russian/Ukraine war will impact sites enrolling in Russia, Ukraine and Belarus:

“Our AR-301 clinical trial currently has sites enrolling in Russia, Ukraine and Belarus. To the extent the conflict between Ukraine and Russia adversely impacts our ability to enrol patients or complete enrollments in process, or adversely impacts the ability of our suppliers to produce and distribute the supplies we need for our AR-301 clinical trial, the timing for completing our AR-301 trial may be adversely impacted.”

In addition, a trial comparing omadacycline with moxifloxacin for the treatment of community-acquired bacterial pneumonia by Paratek Pharmaceuticals has also been disrupted. According to the sponsor, the study has been enrolling since February, including at investigator sites in Ukraine and Russia. “Enrollment in Ukraine and Russia has been placed on hold in response to the Ukraine-Russia crisis that began in February 2022.”

Late-phase trials are currently being impacted the most due to enrolment issues. Due to the invasion and current economic turmoil, sponsors may choose other European nations in which to conduct studies, which will have further impacts on Russia’s pharmaceutical standing.