CLINICAL OPERATIONS AND OUTSOURCING
sponsored, multi-country trials listed as having a site in Russia. However, the reality is that many international pharmaceutical companies have announced publicly they are exiting the country. Bristol Myers Squibb (BMS) is on the more
extreme end of the spectrum, completely severing its ties to Russia. It started to hand over its local operations to its Russian distribution partner Swixx Healthcare in May, with the aim of closing all of its sponsored studies in Russia by the end of June 2022. Andrianov says BMS pulling out elicited an emotional response from patients and clinicians, with the company having had several trials with around 2,000 patients in the country. BMS did not respond to a request for comment at the time of writing. Patients in international trials with
discontinued local sites are likely to have been shifted to other studies or integrated to government-sponsored programmes, Andrianov says. Clinical trials staff that uncertainty, he notes, adding that among staff working for Russian companies, there is more stability but “they are a bit nervous”. Dana Leff Niedzielska, co-founder and CEO of the CRO August Research, says parts of the sector are unlikely to discount Russia as a potential clinical trial destination in the future due to the country having a deep pool of patients. However, as it stands, it is hard to know when, how, or if this is possible, she adds.
How sponsors have been affected A total of 23 sponsors have revealed that the war would affect their respective multi- country trials. The GlobalData database shows that four out of 28 impacted trials have been terminated, with 24 studies still listed as ongoing. Intra-Cellular Therapies has had four trials affected, while Camurus and Vicore Pharma have two studies each. Intra-Cellular has announced that three separate Phase III lumateperone tosylate trials (NCT05061706, NCT04985942, and NCT05061719) for major depressive disorder have been affected. The fourth Phase III study (NCT04285515) is recruiting bipolar depression and major depressive disorder
32 | Outsourcing in Clinical Trials Handbook
patients. Camurus has two different Phase III octreotide trials (NCT04125836, NCT04076462) in acromegaly, with both studies having sites in Russia. Vicore Pharma’s two studies testing VP-01 were disrupted: one Phase II/III trial in COVID-19 (NCT04880642) and a Phase (NCT04533022). Both Intra-Cellular Therapies and Vicore have sites in Russia and Ukraine, with the companies separately indicating that enrolment and recruitment could be impacted by the war. These three companies did not respond to a comment request at the time of writing. Since the war started, GlobalData has been monitoring and tracking both disrupted and potentially disrupted clinical trials. Information from GlobalData’s Clinical Trials Database is sourced from more than 140 clinical trials registries worldwide, alongside clinical conferences, press releases, company
Optimism in Ukraine Back in Ukraine, Vyshnyvetskyy is optimistic. The challenge now is to prove that Ukraine is still a reliable place to conduct clinical trials, he says. There have been regulatory moves to expedite the approvals process in initiating studies, he adds.
Another potential challenge is that some staff – such as clinical research associates – that have left Ukraine may choose not to return, Vyshnyvetskyy notes. Despite the COVID-19 pandemic paving the way for remote monitoring to become a standard part of trials, some study elements still require onsite visits, he explains. Most importantly, Dr Oleksii Korzh, head of the Department of General Practice at Kharkiv Medical Academy of Postgraduate Education, says the ultimate challenge is to ensure the safety of patients and investigators. Korzh and Vyshnyvetskyy agree that it is imperative for Ukraine to remain as an attractive host to trials, with Vyshnyvetskyy explaining that this sector is going to be a key foundation to the country’s healthcare and economic rebuild. “We can demonstrate resilience.”
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