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May 19, 2022

Further trial disruptions due to the Russian invasion of Ukraine

A further three trials have been disrupted by the Russia-Ukraine conflict since 28 April, bringing the total number to 11.

By GlobalData Healthcare

With the turmoil surrounding Russia and Ukraine, there has been an impact on the pharmaceutical industry in both countries. GlobalData has been monitoring trial disruptions since the invasion began.

According to GlobalData’s Clinical Trials Database, a further three trials have been disrupted since 28 April, bringing the total number of disruptions to 11. Eight trials may also have been impacted by the invasion. Out of the disrupted trials, seven are in Phase III and four are in Phase II.

One study that has already been disrupted is a trial by Argenx that is investigating the efficacy, safety and tolerability of efgartigimod PH20 SC in adult patients with pemphigus. According to the sponsor, the war will impact enrollment in both Russia and Ukraine:

“Due to the conflict, we are in some cases unable to ship samples from research sites to our third party central laboratory for analysis, recruited patients may no longer be able to participate in our clinical trials, and difficulties with recruiting patients in Russia and Ukraine might have an indirect limited impact on our business actives as we seek alternative recruitment options. Study data collected at Russian or Ukrainian sites may not be fit for submission due to incompleteness or due practical limitations on auditability of the data.”

Two trials by Vicore Pharma have also been disrupted. One trial is investigating patient recovery from Covid-19 with C-21, while the other trial is investigating the safety, efficacy and pharmacokinetics of C21 in subjects with idiopathic pulmonary fibrosis. According to the sponsor, recruitment for both trials in Russia and Ukraine was stopped due to the current situation.

At present, late-phase trials are being impacted the most due to enrollment issues. Due to the invasion and current economic turmoil, sponsors may choose other European nations to conduct studies, which will have a further impact on Russia’s standing in the pharmaceutical industry.

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