Impact of the war in Ukraine on methodological aspects of ongoing clinical trials - Scientific guideline
Table of contents
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 safeguarding the safety of trial participants as a first 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:
For more information, see Clinical trials in human medicines.
Keywords: War in Ukraine, ongoing clinical trials, protocol deviations, data collection, unblinding, trial integrity, interpretability, estimands framework, COVID-19, scientific advice