By Manas Mishra
– The Russian invasion of Ukraine has left drugmakers scrambling to find ways for patients enrolled in clinical trials there to receive their medicines as millions seek shelter from bombardment and flee to neighboring countries.
Ukraine, as well as Russia, have become important countries for studying new drugs because patients there have a dire need for medicines to treat cancer, neurological and gastrointestinal disorders. Russia and surrounding countries account for 10% of people in clinical trials, analysts estimate.
Russia’s two-week-old invasion and bombardment of Ukraine has rapidly created a humanitarian crisis, curtailing access to food, water and medical supplies and damaging hospitals in major cities. More than 2 million people have fled Ukraine.
“The health system is becoming engulfed in this conflict, engulfed in this crisis,” the World Health Organization’s emergencies director Mike Ryan said this week. “We’ve seen now that some hospitals are being abandoned by the authorities because they simply cannot function.”
Two of the pharmaceutical companies with the most clinical trials in Ukraine – U.S.-based Merck & Co and Swiss drugmaker Roche – said they were assessing how to continue delivering medicines to patients. Combined they have about 100 clinical trials underway there.
At least seven companies, including Pfizer Inc, have said they are experiencing disruptions to trials or patient enrollment in the region. The full scope of delays in Ukraine is unknown. But there were 502 ongoing trials in Ukraine, according to research firm GlobalData.
Roche alone has 33 trials underway in Ukraine accounting for 1.5% of the active trial population across its global studies.
A Roche spokesperson said the company is trying to identify sites in nearby countries like Poland, Slovakia and Romania that could take on its patients in clinical studies.
“The situation for those patients is currently very challenging and we are actively working on solutions to ensure continued access to treatment for these patients, including if they have left Ukraine and moved to other countries,” the spokesperson said in an email.
Patient visits to clinics in the Ukraine capital Kyiv run by Laboratory Corporation of America, which conducts trials for drugmakers, have been canceled since the week beginning Feb. 21, LabCorp told Reuters.
Paul Evans, chief executive of Velocity Clinical Research, which does not currently operate in Europe, said the industry faced similar challenges in the region when Russia annexed Crimea in 2014.
“But that wasn’t an all-out war situation,” said Evans, adding that conducting research in Ukraine now is nearly impossible. “You can probably finish existing trials in Russia. But there is probably a disincentive to starting a new trial there.”
PATIENT RECRUITMENT ON PAUSE
Pharmaceutical companies often run large clinical trials across many countries. Ukraine and Russia have been sought after given a willing patient population and lower cost of doing business compared to the United States and Western Europe.
Jefferies analyst Chris Howerton said trials in Ukraine provide access not only to the experimental drugs, but medicines they are tested against. Trials still enrolling patients will likely shift to other areas if the war drags on, he said.
Merck, which has nearly 60 ongoing trials in Ukraine – the most among all companies operating there – said it had paused enrolling new patients in Ukraine and Russia. The company said on Monday at a conference that it was trying to get products to people enrolled in trials as well as to commercial customers.
Mounting sanctions against Russia do not include medicines. There are 842 trials underway in Russia, making it the sixth largest site for clinical studies worldwide, according to GlobalData.
But experts also cited fresh challenges to conducting clinical business in Russia, such as lack of air travel for investigators outside the country.
Johnson & Johnson said it had paused screening and enrollment of new patients in Ukraine, as well as in Russia and its ally Belarus.
Pfizer, which said it was conducting 27 clinical trials in Ukraine, has paused recruitment of new patients.
U.S. drug developer Karuna Therapeutics suspended enrollment for a trial of its lead schizophrenia drug in Ukraine. Chief Executive Steven Paul told Reuters it could recruit more patients in the United States, if needed.
California-based Tricida Inc said it expected to report data from a trial of its experimental kidney disease drug in the fourth quarter instead of the third, as 15% of patients in the study were from Ukraine.
Said Velocity’s Evans: “In Ukraine, you’ve got a complete breakdown of society there. You can’t possibly be doing clinical research in a war zone like that now.”
(Reporting by Manas Mishra in Bengaluru; Editing by Ankur Banerjee, Caroline Humer and Bill Berkrot)