Another Casualty of the War in Ukraine: Clinical Trials

August 03, 2022
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Since the war in Ukraine began it has upended the lives of tens of millions of people. Nothing in the country is “normal,” anymore and as you can imagine, that includes Ukraine clinical trials, which normally a very robust environment, with around 500 trials ongoing every year from approximately 2,500 public medical facilities in Ukraine.
In normal times, clinical trial sponsors and managers in Ukraine benefit from an uncommonly high success rate in clinical trial recruitment. This is due to a combination of the country’s reputation for high-quality research and medical capacity, and an underfunded healthcare system, creating a population eager to join clinical studies as an option for receiving vital treatment. This has made Ukraine an attractive setting for pharmaceutical industry trial sponsors (Holt, 2022).
The result of the war has been the suspension of many clinical trials and disruption of treatment for untold numbers of patients. Recruitment has been halted for many clinical trials amid the turmoil and destruction of a war in which medical treatment and research facilities have been deliberately targeted. Just before the invasion, there were hundreds of clinical trials under way in Ukraine. A quick search at clinicaltrials.gov (NIH) lists nearly 400 clinical trials based in the country, with hundreds of areas of study in scores of conditions, including various cancer trials, COVID-19 studies, and research into pulmonary disease, neurological disease, multiple sclerosis, and schizophrenia, to name a few.
Ukraine is vital to many clinical trials based outside of the country as well. If you search the same NIH database for all trials that have at least one research site in Ukraine, nearly 600 are listed. So, the war has not only hindered drug and device testing for both Ukraine-based trials but also those based in other countries that have Ukraine research sites.
Just before the beginning of the conflict, the FDA database showed 251 drugs and devices undergoing trials. Recruitment efforts for many of those trials have been halted, not only by the war, but by sanctions placed on Russia because of its aggression (Hoey, et al.).
Still, some study and research does continue, as devoted researchers try to keep up with work that they can do in the current conditions. This includes research sponsored by pharmaceutical companies Merck and Roche, among others. In some cases, patients are being given the opportunity to continue with the treatment they have been receiving in their trials. These efforts have included moving trial participants living in unsafe areas to other places, within and outside Ukraine, where they can continue their treatment in relative safety. In other cases, medical supplies for clinical trials are even being delivered to areas with heavy fighting so studies can continue. (Holt, 2022)
Another risk to clinical trials during the Ukraine war is trial subjects who become refugees or are internally displaced, resulting in trial subjects and their medical records becoming scattered, perhaps to the point where information regarding their outcomes is irretrievable.
Drug development supply pipelines in the United States and the European Union are also experiencing delays caused by the war, according to an article in The Scientist (Zimmer, 2022). Enamine, a biotech firm located in Kyiv, creates synthetic compounds used in developing therapeutics and supplies them to pharmaceutical companies around the world. In a March 7 statement, Enamine CEO Andrey Tolmachov reported that the company was temporarily putting its Kyiv operations on hold because of the growing war, but was taking a number of immediate steps to stabilize and resume operations, including transferring all digital data to safe servers outside Ukraine, working with the Ukraine government to create logistical supply lines to replenish E.U. and U.S. stocks of compounds, reagents and building blocks as soon as possible, and relocating some of its staff of chemists outside Ukraine to Latvia.
“It is an extremely challenging time for us, but Ukraine will stand,” Tolmachov wrote. “And Enamine will stand as well.”
Clinical trials in Russia will also suffer from the war in Ukraine as many biotechnology and pharmaceutical companies pull back investments and halt trials in Russia because of sanctions and company principles. Pfizer, Eli Lilly, and GlaxoSmithKline are among the major companies that have announced that they will not start new clinical trials in Russia. At the same time, pharmaceutical and biotech companies are supporting Ukraine in this difficult time. Lilly is still providing lifesaving medicines to Russia for people suffering from diseases such as cancer and diabetes but has pledged to donate any profits from those sales to humanitarian causes. As of late March, Pfizer provided $1 million in humanitarian grants to Ukraine, Bayer set up a $3 million relief fund, and Sanofi has donated more than $5 million to relief efforts (Mulero, 2022).
It is difficult to quantify how wide-ranging the effects the war in Ukraine will be to clinical trials both inside and outside the country. Clinical Trial Guide will continue to monitor the situation as the conflict progresses.
References
Brown, G. (2022, March 14) The war puts Ukraine’s clinical trials—and patients—in jeopardy. WIRED. https://www.wired.com/story/war-ukraine-clinical-trials-jeopardy/
Hoey, T., Miller C., & Roach, S. (2022, May 12). Current state of clinical trials impacted by the war in Ukraine. Insights. Halloran Consulting Group. https://www.hallorancg.com/2022/05/12/current-state-of-clinical-trials-impacted-by-the-war-in-ukraine
Holt, E. (2022, April 30) Clinical triallists in Ukraine determined to continue. The Lancet, 399(10336), 1680-1681. https://doi.org/10.1016/S0140-6736(22)00773-5
Munero, A. (2022, March 23). Ukraine-Russia war pushes big pharma into mixed response. HealthLeaders. https://www.healthleadersmedia.com/pharma/ukraine-russia-war-pushes-big-pharma-mixed-response
Zimmer, K. (2022, March 28) Amid the terror of war, efforts to keep science alive in Ukraine. The Scientist. https://www.the-scientist.com/news-opinion/amid-the-terror-of-war-efforts-to-keep-science-alive-in-ukraine-69846

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