Points to Consider on the Impact of the War in Ukraine on Methodological Aspects of Ongoing Clinical Trials

On 13 April 2022 the EMA published guidance on actions for ongoing clinical trials affected by the war in Ukraine.

This guidance covers actions that sponsors of ongoing clinical trials affected by the war in Ukraine can take to help ensure the integrity of their studies and the interpretation of the study results while ensuring the safety of trial participants is a top priority.

EMA strongly encourages sponsors to capture data affected and unaffected by the war, and to use the 'estimand framework' described in the ICH E9 (R1) guideline for dealing with events impacting the trial.

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