Clinical Trials in Human Medicines: Management of Clinical Trials Impacted by the War in Ukraine

On 31 March 2022 the FDA published the advice to sponsors on management of clinical trials impacted by the war in Ukraine.

Sponsors can adjust the way they run clinical trials that have been affected by the war in Ukraine using the experience gained during the COVID-19 pandemic. They can also apply the approaches and flexibilities agreed in the context of the pandemic.

The European Commission, EMA and the Heads of Medicines Agencies (HMA) issued this initial advice for sponsors on 30 March 2022.

The Clinical Trials Coordination Group (an HMA group uniting clinical trials experts) is developing additional recommendations for sponsors.

EMA is developing recommendations on the methodological aspects relating to data from clinical trials that have been affected by the war.

EMA advises sponsors to also check any guidance available at national level.

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