Europe – Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trials

The war in Ukraine is expected to lead to disruptions in the conduct and planning of clinical trials. While more severe disruptions are expected in Ukraine, other countries are also affected in several ways, e.g. due to the arrival of refugees fleeing from Ukraine or due to impact of imposed sanctions. The direct or indirect impact of war-related events on trial participants, sites, logistics, etc. is likely to interfere with ongoing trials in several countries, not limited to the collection, analysis and interpretation of clinical trial data.
Most importantly, safety of study participants is the absolute priority and must be at the heart of every decision taken, regardless of any potential consequences for an ongoing trial. Secondly, whenever feasible and in the interest of their continuing care, patients should be offered to continue receiving treatment (even if this might require unblinding at individual patient level) and supported to stay in the trial as long as this does not imply a safety risk. Consequently, Sponsors should prioritise the interests of patients already enrolled in the trial while considering the future conduct and continued feasibility of
the trial from an ethical, medical and methodological perspective…