Sponsors testing drugs in Eastern Europe will need to take a flexible approach and be willing to adjust trial plans as a result of current Russian president Vladimir Putin’s war in Ukraine.
The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued the advice last week, suggesting sponsors should expect disruption.
“The ongoing war in Ukraine may require sponsors to adjust the way clinical trials are run in this region, and sponsors may need advice on how to deal with the impact of protocol deviations and other consequences of the disruptions.
“Certain changes and protocol deviations in the current situation are unavoidable, when for example scheduled study visits cannot take place, or arrangements need to be made to transfer trial participants who are fleeing Ukraine to other investigator sites of the same trial in the EU.”
They also said certain adaptations will be needed to protect the participants’ right and safety, including the continuation of ongoing treatment if possible, as well as to preserve the quality of trial data.
According to the EC, EMA and HMA sponsors and CROs need to use strategies developed in response to the coronavirus pandemic to mitigate against disruption.
“Where applicable, sponsors are advised to use the experience gained during the COVID-19 pandemic and apply the approaches and flexibilities agreed in this context” the organizations wrote, citing guidance documents on trial management and study methods.
The EC also said the EMA and HMA are developing specific advice.
“In view of the specific circumstances linked to the war in Ukraine, the Clinical Trials Coordination Group clinical trials is developing additional recommendations for sponsors.
“EMA will develop additional recommendations on the methodological aspects of data stemming from clinical trials impacted by the war in Ukraine.”
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