CLINICAL OPERATIONS AND OUTSOURCING
As Russia’s clinical trial sector falls, Ukraine rebuilds
Reynald Castañeda analyses the impact of the war on the clinical trial landscapes of Ukraine and Russia, as local investigators chronicle the situation on the ground.
I
t’s now 10 months since the start of Russia’s war in Ukraine. A United Nations update on 15 August reported that about 5,514 civilians had died and 7,698 people had been injured, with the actual figures likely to be considerably higher. The war is still doing huge damage to the economies of both countries due to the military invasion in Ukraine and companies pulling out of Russia. Focusing on the clinical trials landscape, as of August 2022, 28 foreign-sponsored, multi- country studies were publicly acknowledged by sponsors as being impacted by the war, according to GlobalData’s Clinical Trials Database. Of these, almost half had sites in both Ukraine and Russia. That said, the war’s ripple effects are likely to be far-reaching. Currently, the clinical trials sectors of both
countries appear to be on different paths. Ukrainian Association for Clinical Research president Dr Ivan Vyshnyvetskyy says that Ukraine’s local activity is on the road to recovery. In fact, several studies are back to recruiting participants locally, and new studies have been initiating in the past several months, he adds. “At some point we started working like business as usual.” In Russia, it’s a different story. Dr Vladimir Andrianov recently left his position as director of the Department of Clinical Trials at the First Moscow State Medical University. Andrianov also left Russia.
Ukraine war froze clinical trial activity When the Ukraine war started, clinical trial activity in the country was frozen, Vyshnyvetskyy recollects. While some overseas-sponsored studies with recruited patients managed to continue, investigations with a small number
30 | Outsourcing in Clinical Trials Handbook
Dr Ivan Vyshnyvetskyy, president of the Ukrainian Association for Clinical Research.
of participants or ones that are yet to recruit had local sites scrapped or put on hold, he adds. “Nobody knew what to do next because players did not know when the full-scale aggression would stop.” The war has impacted clinical trials in different ways. Non-Ukraine trial sites in multinational studies may have had to recruit more participants to compensate for Ukraine global clinical research officer at CRO Biomapas, which has its headquarters in Lithuania. As another consequence, patients might
have been dropped from non-critical studies in order to prioritise the safety of Ukrainian trial they would have been replaced by participants from sites in neighbouring countries. There is the option of adding more non-Ukraine sites and countries in the study, but it can be costly.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
