Clinical trials in Ukraine – overcoming disruption
Protocol deviations, trial redesign and contingency planning are all realities for sponsors running clinical trials in Ukraine during the war. Disruptions are unavoidable, for example when scheduled study visits cannot take place, or arrangements need to be made to transfer trial participants who are fleeing Ukraine, to sites in a different country.
Adaptations are required to protect participants’ privacy and treatment regime, including the continuation of ongoing dosing if possible, as well as preservation of data quality generated by the studies.
Despite these disruptions, sponsors and their clinical trial supply chain partners are ensuring that ongoing studies are progressing, and that the processes and infrastructure are in place to resume new start-ups.
Agenda:
The Ukrainian clinical trial market: current situation
Regulation updates: Recommendations from Ukraine’s MoH State Expert Center
A first-hand account of the challenges of clinical trials from stakeholders
New solutions for overcoming disruptions in Ukraine