New global data analysis from Phesi shows the extent of the impact from the war in Ukraine on clinical development.
Phesi analysed pivotal trials sponsored by pharmaceutical companies that represent the most critical global clinical development activities.
The findings show that as of March 16, 2022, there were 65,593 recruiting investigator sites globally in this category. Of these, 2,911 (4.4%) sites were based in Ukraine and Russia (Figure 1), with the majority of pharmaceutical trials currently in Phase III. Investigator sites in these countries are now on hold or have been cancelled, due to the ongoing conflict, accompanying supply issues, and financial sanctions that have been issued. A further 1,738 (2.6%) sites in neighboring Poland are also now at elevated risk as the war continues.
For some indications, the scale of the global development programmes undertaken, and thus the proportion of sites impacted by the war, will be particularly difficult to manage. For instance, more than a quarter (26%) of all trials in Schizophrenia take place in Ukraine and Russia, as well as a high proportion of gastrointestinal disease studies – including Ulcerative Colitis (14%) and Crohn’s Disease (10%). Moreover, disruption is not evenly distributed among sponsors. Ironically, it’s those with a global development strategy that will be hit harder; 8% of all Eli Lilly and Company sites are in Ukraine and Russia, and 7% of all Merck Sharpe & Dohme sites (Figure 3).
“Whilst the war is happening in a single country, the impact for the clinical development industry will be global and long-lasting. Coming on top of the pandemic and with many countries still implementing lockdowns, it’s an increasingly difficult time for pharmaceutical companies,” commented Dr Gen Li, CEO and Founder, Phesi. “Redistributing investigator sites will be painful, costly, and chaotic. I am hopeful that the industry will apply the lessons learned during the pandemic about the importance of a data-driven approach. This will minimize the disruption and keep some studies going, while ensuring the safety of patients and investigators comes first. This means stopping the recruitment of new patients in affected regions now, and wherever possible, conducting studies remotely and virtually.”
“Sites in Ukraine, Russia, and Poland contribute significantly more patients on average, which exacerbates the impact beyond the number of sites in just these countries,” commented Dr Paul Chew, Chief Medical Officer, Phesi. “Whilst the region will not see many trials returning in the short-term, we urge sponsors to retain their links with investigators and academics based there and keep the lines of communication open. They should also continue to fund sites, even those that are suspended. They must speak to regulators and CROs about how to maintain data integrity. Finally, sponsors should explore how existing data as well as synthetic data can supplement studies to get trials over the line. There may already be enough data available to close knowledge gaps and get urgently needed treatments out to patients.”