Clinical tech services company Phesi has released a report showing the extent of the impact of the war in Ukraine on clinical development. The report takes a look at “pivotal” trials sponsored by pharmaceutical companies that represent the most critical global clinical development activities.
According to the findings, 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 (see figure 1), with the majority of pharmaceutical trials currently in Phase III. Investigator sites in these countries are now on hold or have been canceled, 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.
Gen Li, Phesi CEO and founder, told Outsourcing-Pharma that while the world hopes for a swift end to the war in Ukraine, clinical development in the country likely will still take a significant amount of time to recover.
“In the short term, it would be unlikely for trials in Ukraine to get back up and running quickly given the other understandable priorities that the country will have,” he commented. “However, in the medium to long term, I would expect Ukraine to reassume its role as a critical location for clinical development; right now, it’s important to prioritize the safety of investigators and patients in the country.”
He also said he believes new recruitment should be halted, while he urged sponsors to continue funding sites, even those unable to operate.
“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,” Li added. “Redistributing investigator sites will be painful, costly, and chaotic.”
While the current and future effects of the conflict on research activity are apparent, Phesi added, he remains hopeful that the industry will be able to apply what has been learned during the COVID-19 pandemic about how important a data-driven approach can be.
“This will minimize the disruption and keep some studies going while ensuring the safety of patients and investigators comes first,” he commented. “This means stopping the recruitment of new patients in affected regions now, and wherever possible, conducting studies remotely and virtually.”
The findings also reveal that the proportion of sites impacted by the war likely will be especially difficult to manage—more than a quarter (26%) of all trials in schizophrenia currently take place in Ukraine and Russia, as well as a high proportion of gastrointestinal disease studies, like ulcerative colitis (14%) and Crohn’s disease (10%).
What’s more, disruption appears to be unevenly distributed among sponsors. Those with a more global development strategy are likely to be hit the hardest; 8% of all Eli Lilly sites are in Ukraine and Russia, and 7% of all Merck Sharpe and Dohme sites (figure 3).
“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 Paul Chew, chief medical officer of 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.”
Chew added he believe sponsors should continue to fund sites (including suspended ones), work with regulators and CROs on solutions to maintain data integrity, and explore how existing and synthetic data might help them “get trials over the line.”
“There may already be enough data available to close knowledge gaps and get urgently needed treatments out to patients,” Chew remarked.
Li stated trials in Russia also are being impacted by the Ukraine war.
“When it comes to Russia, we’ve already seen that many large pharmaceuticals companies have said that they won’t conduct trials in Russia in the immediate future, like GSK for instance,” he said. “Financial sanctions will also have an impact. I believe it will take some time before Russia will play an international role in clinical development again."