With the uncertainty surrounding Russia and Ukraine, it is expected that there will be a large impact on the pharmaceutical industry. More specifically, early phase clinical trials in that region could be disrupted says GlobalData.

Data from GlobalData’s Clinical Trials Database shows that both Russia and Ukraine have a significant number of planned and ongoing trials. Since February 28, Russia’s ongoing, recruiting trials have slightly increased from 1005 to 1008. Planned trials have also increased from 835 to 842 trials. For Ukraine, the number of ongoing recruiting trials has increased from 499 trials to 502 trials, and the number of planned trials has remained consistent daily. However, it may take time for disruptions to be reflected in clinical trial registries; in fact, the State Expert Center of the Ministry of Health of Ukraine’s website for the clinical trials registry is currently not functional.

Priya Nair, Trials Intelligence Analyst at GlobalData, comments: “It is becoming more prevalent that clinical trials with a location in Russia or Ukraine will be disrupted, and if those trials are multinational, the disruption could create a ripple effect. If the crisis escalates, it could create hurdles for patient recruitment and the ability of both patients and investigators to reach trial sites.”

Sponsors have begun to observe the situation and have begun discussions of potential disruptions to clinical trials. For example, Jounce Therapeutics released a statement warning that economic and other sanctions on Russia could disrupt or delay its ability to conduct clinical trial activities, including the evaluation of safety or efficacy data. Additionally, Pieris Pharmaceuticals released a statement claiming that its study of PRS-060/AZD1402, which had sites located in Ukraine, could disrupt “clinical development efforts.”

Nair continues: “International sponsors currently seem to be reluctant to completely halt trial operations in both Russia and Ukraine and are possibly waiting for a political truce between both nations. Countries such as India also heavily rely on drug exports from Russia, especially for the distribution of the Sputnik vaccine. Disrupting distribution due to the crisis will heavily impact India and other nations, so a cautious approach is expected. Moreover, to completely stop trial recruitment in Ukraine would mean sponsors would have to suspend trials completely or find alternative sites, which may prove costly.”

According to GlobalData, within Europe, Russia is the sixth largest conductor of industry-sponsored clinical trials. Russia’s clinical trial pipeline is heavily focused on Phase I industry-sponsored trials, and within Europe they are the third largest nation to conduct Phase I trials.

Nair concludes: “If trial disruptions were to occur due to the Russia-Ukraine uncertainty, many early phase trials would be impacted.”