Russia’s attack on Ukraine has cascading effects on a variety of sectors, including the development of new drugs and therapies. “Both countries are considered two major hubs of global clinical research,” he confirms Giuseppe Novelli, geneticist at the Tor Vergata University of Rome. “In fact, there are numerous clinical trials underway or planned – or at least they were before the war – in both countries. With their ‘leaner’ bureaucracy and lower costs – he adds – it is not surprising that Ukraine is that Russia are considered an attractive pole for the pharmaceutical industry and for biotech companies “. At least it was like that before the war. For both Ukraine and Russia. Now there are over a thousand studies and clinical trials at risk.
War in Ukraine, neuropsychiatrists: long-term damage to the psyche of children
Studies and clinical trials slowed by conflict
Specifically, according to the clinical research organization Global Clinical Trials, Ukraine is home to approximately 2,500 public medical facilities that have experience in conducting international studies and more than 500 trials are carried out each year. The data present in the database of clinical studies of the Food and drug administration speak of 251 drugs and medical devices subject to clinical studies that have at least one site in Ukraine.
According to Clinical Trials Arena, in Ukraine at risk there would be at least 680 ongoing or planned clinical trials. While for the database of clinical trials GlobalData they would instead be over a thousand. The vast majority of these studies are surveys involving many countries and 14 have Ukraine as their recruiting sites.
War in Ukraine, the psychiatrist: “Putin will not stop. He feels he is the savior of the homeland”
by Valeria Pini
The database divides the studies according to the therapeutic area and based on these data most of them concern the oncology sector with a total of 786 studies. The first five therapeutic areas are completed by experiments on the central nervous system (182), on infectious diseases (127), on gastroenterology (116) and on cardiovascular diseases (105). If, on the other hand, diseases are considered, the first five ongoing and planned clinical trials at sites located in Ukraine concern lung cancer (99 studies), breast cancer (78), ulcerative colitis (44), Covid-19 ( 35) and Crohn’s disease (31). There are also studies that cover more than one therapeutic area or more than one disease.
War in Ukraine, the appeal of psychotherapists: “Let’s stop the conflict”
Research on schizophrenia is at stake, but not only
It is clear that there is a good chunk of the future of medicine at stake and the war could shatter all plans, as evidenced by recent statements by some CEOs of dozens of biotech companies. American biotech Karuna Therapeuticsfor example, he said the timing for his second Phase III “Emergent-3” schizophrenia study is uncertain, because 10 of the 19 trial sites are in Ukraine.
11 of the 195 sites for Merck’s phase III study of Keytruda in combination with Lenvima in patients with endometrial cancer are also in Ukraine. Regeneron is testing its lung cancer drug GlaxoSmithKline in 6 Ukrainian sites in its phase III trial of otilimab in patients with rheumatoid arthritis, GlaxoSmithKline has 27 sites in Ukraine. AstraZeneca has 20 ongoing studies, while Sanofi has two. At risk there is also Incyte, the program for the study of Pd-l1 in solid tumors: 70% of the sites are in fact located in Ukraine.
War in Ukraine, 7-year-old girl fleeing bombs to treat cancer in Italy
Russia was the sixth country for major ongoing or planned clinical trials
Even studies in Russia risk big. It is no coincidence that last week thousands of Russian scientists, doctors and journalists wrote a courageous letter addressed to Putin in which it is emphasized that medicine, and science in general, in Russia risk being left behind. “But the truth is that medicine and world science are in danger of losing a lot”, underlines Novelli. It is no coincidence that Russia ranks sixth among European countries, with Germany, the United Kingdom, Spain, France and Italy at the top of the list of countries with the largest ongoing or planned clinical trials. Indeed, Russia’s footprint in clinical trials has increased over the years: the number of studies has increased from 71 in 2017 to 797 in 2021.
War in Ukraine, 7-year-old girl fleeing bombs to treat cancer in Italy
The main therapeutic areas with an ongoing or planned clinical trial involving at least one site in Russia are oncology (561 studies), central nervous system disorders (310), infectious diseases (253), cardiovascular diseases (228 ) and then gastrointestinal problems (168). Looking at the companies sponsoring ongoing and planned Phase I-III studies in Russia, we find Merck with 96 studies, Novartis with 90, Roche with 79, AstraZeneca with 74 and Johnson & Johnson with 59 studies at the top of the list.
War in Ukraine, 7-year-old girl fleeing bombs to treat cancer in Italy
The difficulty of recruiting patients
“Russia is an interesting destination for clinical trials thanks also to the large population which allows for faster recruitment,” says Novelli. Given the operational benefits, many multinationals have turned to Russia to host their clinical trials. There are 125 US-based companies with 508 ongoing and planned clinical trials in Russia. In addition, there are 134 companies based in Europe (excluding Russia) with 659 trials.
War in Ukraine, the psychiatrist: “The spouses under the bombs and the dream of stability and security”
At the moment we have no news of clinical trial interruptions in Russia. However, some companies like Intra-Cellular Therapies and Protagonist Therapeutics have begun to recognize that their trials are at risk, particularly patient recruitment. Jounce Therapeutics reports that local tensions and economic sanctions against Russia could cause the country’s ability to set up a trial to be disrupted or delayed. For example, Jounce’s Phase II SELECT study of 75 patients, which aims to study the PD-1 inhibitor JTX-4014 in non-small cell lung cancer, has 14 sites in Ukraine and 17 in Russia, while the rest of the sites are in neighboring countries.
War in Ukraine, 7-year-old girl fleeing bombs to treat cancer in Italy
Over the years, Russia has become a major host for Phase I clinical trials, thanks to the presence of many clinical trial sites specializing in early stage research. In fact, more than a quarter of all ongoing and planned studies are in Phase I (502), second only to Phase III studies (911). Due to the uncertainty of this war, there are doubts as to whether these studies can continue or begin. Most of the planned and industry sponsored trials are in Phase I (529 studies), followed by Phase III (185).
Ukraine, how we save the 50 children with cancer in Kiev from the war
by Donatella Zorzetto
Sanctions also affect the conduct of studies
That said, these planned tests are mostly sponsored by companies based in Russia, with only 177 studies sponsored by companies based in the United States or other parts of Europe. Of the 177 planned trials, at the top of the sponsor list are Pharmatechnology (12 trials), Berlin-Chemie (9), Richter Gedeon (9), Krka (8) and Novartis (8). And when classified according to the therapeutic area, these studies mainly concern cardiovascular diseases (40), central nervous system disorders (27) and infectious diseases (23). Most worryingly, 122 of these 177 trials were scheduled to recruit in Russia alone. Should sanctions remain or intensify, these studies could experience significant delays. “It would be a serious loss for science, a serious loss for humanity”, concludes Novelli.
Science and war. Four girls on the night of the bombs
by Angelo Vescovi
