Ukraine conflict—initial advice for clinical trial sponsors published

Article summary

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued initial advice for sponsors regarding how to manage the conduct of clinical trials in light of Russia’s invasion of Ukraine. The EMA and HMA confirm that certain changes and protocol deviations are unavoidable in the circumstances and state that adaptations, such as the continuation of ongoing trial treatment, will be required to protect participants’ rights and safety. They also advise sponsors to use the experience gained during the coronavirus (COVID-19) pandemic and apply the approaches and flexibilities agreed in the current context. In addition, the HMA confirmed that the Clinical Trials Coordination Group is developing additional recommendations for sponsors and the EMA will develop additional recommendations on the methodological aspects of data stemming from clinical trials impacted by the Ukrainian conflict.