European regulators are warning that clinical trial protocol deviations are "unavoidable" for studies operating in Ukraine amid the Russian invasion, and companies should consider being flexible as they have been during the COVID-19 pandemic to keep vital research going.
The advice from the European Commission, the European Medicines Agency and the Heads of Medicines Agencies comes after sponsors in Ukraine or close to the situation asked for guidance regarding trial records, documentation, data collection, protocol deviations and the potential impact missing data could have on methodology.
New research shows that more than 4% of global trials have had to be halted or paused due to instability in the region. Most recently, Aeterna Zentaris announced plans to push recruitment for a phase 3 trial of a diagnostic test in children into 2023, citing the war as reason for the delay.
The agencies acknowleged that certain changes are inevitable given the conflict; for instance, scheduled study visits may not be possible, or arrangements must be made for trial participants fleeing Ukraine to transfer to other sites in the EU. Other necessary adjustments include protecting participants’ rights and safety, such as continuing ongoing trial treatment if able, and preserving the quality of data.
The agencies are urging sponsors to use the experience gained during the COVID-19 pandemic when possible, advising sponsors to apply related guidance (PDF) and considerations (PDF) now. Sponsors should also check any available national and local resources or authorities for specific guidelines. Additional recommendations are currently in development.
In late February, dozens of industry leaders and investors urged their global business counterparts to “disengage from Russian industry.” Chief executives from Nkarta, BioMarin, Rubius, atai Life Sciences, Blueprint Medicines, Ovid, Global Blood Therapeutics and dozens of others called on biopharma and other industries to “cease investment in Russian companies," in the Feb. 26 letter.