Phesi: Ukraine war will impact global clinical development
The impact of Russia’s invasion of Ukraine is being felt across the world - from the sales of oil and gas to vodka. New data from Phesi, a virtual clinical development company, has shown that clinical trials sponsored by pharmaceutical companies are also being interrupted.
Phesi was founded in 2007 and is headquartered in Connecticut, USA.
Healthcare clinical trials for schizophrenia are on hold due to Russian invasion
Phesi’s findings show that there were 2,911 clinical trial sites based across Ukraine and Russia, out of 65,593 worldwide. The clinical trials due to take place in these sites have now been cancelled or are now on hold.
To the north-west of Ukraine, Poland is safely tucked away behind the red line of NATO. However, the country is supporting up to 2mn Ukrainian refugees, many of whom need urgent healthcare. Poland’s 1,738 medical sites which were used in clinical trials now have other priorities.
On these sites, 26% of all schizophrenia trials take place across Ukraine and Russia, as well as 14% of those looking at Ulcerative Colitis and 10% of those for Crohn’s Disease.
Redistributing clinical trial sites will be 'costly and chaotic'
Whilst the war is happening in one country, Phesi’s CEO and Founder, Dr Gen Li, knows that 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 minimise 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,” agrees Dr Paul Chew, Chief Medical Officer at 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.”
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