In the context of the Russian invasion of Ukraine and its consequences, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies in the European Economic Area (HMA) network have published initial guidance for sponsors of clinical trials operating in Ukraine.
Clinical trial sponsors were seeking guidance to adapt their protocols and methodology to the upheaval caused by Russian military aggression in Ukraine and to try to maintain the quality of the trials.
With Russian aggression, sponsors face many challenges. This includes redirecting participants from these clinical trials to similar studies in the EU or providing participants with continuity of treatment in a clinical trial. Discontinuation of these study treatments could result in an unfavourable diagnostic outcome for some participants.
Due to several factors including its geographical location, but also the large number of untreated patients for sometimes serious diseases and the facilities offered by regulators, Ukraine was an attractive state for clinical trials before the Russian aggression. According to the GlobalData clinical trials research database, nearly 680 trials linked to research sites based in Ukraine were underway until the start of the conflict.
As a first step, the EMA and HMA and the European Commission recommend that sponsors of clinical trials, where possible, draw on the resources set out in two documents developed to address the disruption caused by the Covid-19 pandemic.
The HMA’s Clinical Trials Facilitation and Coordination Group will produce further recommendations. The EMA will provide recommendations on methodological aspects in this specific context.
Sponsors are also encouraged to contact the relevant national authorities in the EU for the supervision and authorisation of clinical trials. (Original version in French by Emilie Vanderhulst)