biggest in history A proponent of clinical trial quality conducted his first trials during the war. British soldier Archibald Cochran is captured by German troops in Thessaloniki, Greece, in 1941. As the only doctor among the 20,000 prisoners, Cochran observed many cases of leg swelling, including his own. He became so desperate that he decided to conduct his own experiments. He sourced yeast from the prison’s black market and divided 40 inmates into two groups: one group received two spoonfuls of yeast a day, the other group received vitamin C tablets. By day four, he determined that the yeast group improved more than the vitamin-treated group. Today we know him as the father of evidence-based medicine; Cochrane called it his “first, worst and most successful clinical trial”.
But make no mistake: War is a huge obstacle to medical research. Russia’s invasion of Ukraine — forcing more than 2.3 million people to flee to nearby countries — was no exception. According to the US Food and Drug Administration’s clinical trials database, there are more than 250 trials conducted at research centers in Ukraine. Of these, 117 involved cancer-related interventions. Others are used to treat conditions such as multiple sclerosis, schizophrenia, and Covid-19 infection.
Now, the war threatens to cut off drug supplies and distract participants, making their health records harder or untraceable. In the clinical world, consistency is king. Gaps in the data can undermine the reliability of any takeaway or siege analysis. Mike Clark, an expert in clinical trial design at Queen’s University Belfast, said any researchers trying to restart a trial would be in a completely different Ukraine than when it started. Health and research infrastructure will still recover, millions will flee, and resources may be scarce. “The environment in which they will start over will be so different that they may have to think of it as two trials,” he said: a trial before the invasion and a trial after the invasion. This is to imagine a scenario where previously collected data is not corrupted. Clark noted that the trials may be almost complete, “but their findings will never be reported now — a complete waste.”
Pausing and restarting trials can not only produce poor data, but can be devastating for patients — especially those with terminal disease, for whom participation in a trial is their last hope. “For cancer patients, it is also a question of survival,” said Ivan Vyshnyvetskyy, president of the Ukrainian Association for Clinical Research.
Ukraine is known for its clinical trial centers. It has a large and capable medical and research workforce and is known for providing reliable data. For years, its health care system was underfunded. This means that participating in a clinical trial becomes an alternative (and often faster) route to care, so patient recruitment is easy. In addition, an unstable health care system means that much of the population is made up of “treatment-naïve patients,” or individuals who have not yet received any treatment, a dream of trial investigators. Over the past few years, Ukraine has overhauled its healthcare system and made digital records the norm, which in turn has made participant recruitment a breeze. But all of those trials are now in grave danger as Putin’s invasion wreaks havoc across the country.
“The main problem is logistics,” Vyshnyvetskyy said. “It is nearly impossible to ship biological samples and investigational medical products from Ukraine from sponsors to Ukraine.” Many of the materials needed for clinical trials are located in Kyiv, a war zone, he said. “So it’s almost impossible to get these materials, even if they’re in Ukraine right now.”