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 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."
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 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)
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