How To Transfer Clinical Trial Participants From Ukraine To EU Sites
An EU expert group and a number of member state agencies have published advice on the practicalities of safely moving Ukrainian clinical trial subjects to sites in EU and European Economic Area countries.
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Decentralized trials are a way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.
The Ukrainian pharma firm Darnitsa, which is the latest firm to benefit from the WHO’s mRNA coronavirus vaccine initiative, says it is continuing production amidst the continuing Russian attacks on the country. Meanwhile, the European Medicines Agency has issued guidance for sponsors on methodological aspects of trials affected by the war.
Amid the continuing conflict and the Russian shelling of hospitals in Ukraine, regulatory bodies, health authorities and clinical research organizations are issuing guidance on how to deal with the impact on clinical trials in both Ukraine and Russia.