EU Advises Use Of Pandemic Flexibilities For Trials In Ukraine
Russian CRO Body Issues Recommendations
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.
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With major disruptions to clinical trials becoming more commonplace due to political conflicts and natural disasters, the European Medicines Agency has developed guidance to help sponsors make risk-based adjustments to manage ongoing studies.
The Russian clinical trials organization ACTO says the “gloomy” prospects for multinational clinical trials in the country have led many sponsors to postpone the initiation of new studies or abandon them entirely in favor of other markets.
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.