04/05/2022

The European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) issued advice to sponsors on how to manage clinical trials that are impacted by the Russian invasion of Ukraine. Sponsors requested advice on how to manage protocol deviations, source documents, missing data, and other changes that are due to the ongoing Ukrainian war. The joint advice references the guidance issued during the COVID-19 pandemic (Guidance on the management of clinical trials during the COVID-19 pandemic and Points to consider on implications of COVID-19 on methodological aspects of ongoing clinical trials). The key takeaway is to approach impacted clinical trials with the same flexibility and alternative approaches that were needed during the pandemic. Reasonable alternatives must continue to protect the safety and rights of study participants and the quality and integrity of the data.

If a study participant fled the Ukraine, they could potentially transfer to an EU clinical site conducting the same trial. It may also be in their best interest to withdraw from the trial. Each situation should be evaluated individually. Applicable regulatory authorities should be consulted for questions. Since clinical trials are authorized and supervised at the national (European Union, or EU) level, it is acceptable to continue study related procedures in a different EU clinical trial site if another transfer was needed.

Additional recommendations for sponsors are being developed by the Clinical Trials Coordination Group, a group of clinical trial experts in the HMA, while recommendations for how to manage impacted data is under development by the EMA. Sponsors should also check for any national guidance applicable to their situation. If further questions remain, sponsors should contact the applicable regulatory authority.