Sustaining oncology clinical trials under wartime conditions: Strategic lessons from Ukraine.

Abstract

1512 Background: On February 24, 2022, when Russia launched its full-scale invasion of Ukraine, our center had already treated more than 5,000 patients across 410 oncology clinical trials (CTs) since 2002. At the onset of the war, 125 active CT contracts across 18 cancer types (64 sponsors) were ongoing, with 413 patients enrolled or under follow-up, including 210 in active treatment (57 CTs), 203 in follow-up (53 CTs), and 15 CTs pending initiation. The sudden transition to wartime conditions posed unprecedented challenges to patient safety, continuity of care, trial operations, regulatory compliance, and data integrity, requiring rapid adaptation of clinical, logistical, and digital infrastructures. Methods: We conducted statistical analyses to evaluate the feasibility of sustaining CTs over 35 consecutive months of martial law. Key domains included personnel retention, trial activity, protocol adherence, supply chain continuity for a research center located 80 miles from the frontline, and digital infrastructure performance, including utilization of the Medical Control Records (MCR) management system. Our goal was to identify factors applicable to clinical research in armed conflict, natural disasters, and other protracted crises. Results: Despite ongoing air raids, missile attacks, power outages, and mass displacement, 99% of scheduled patient visits and data transfers were completed. Of the 413 patients at the start of the war, 150 (36.3%) remain in active treatment (n = 42) or follow-up (n = 108) across 55 trials, representing 44% of the pre-war portfolio. Since February 2022, 7,891 patient visits, 16,155 blood tests, 1,762 tumor response assessments, 3,525 intravenous infusions, and 3,272 oral drug distributions have been completed, with 176 deaths recorded as protocol endpoints. Rapid restoration of supply chains, communications, patient logistics, and secure data management enabled uninterrupted trial activity. A key facilitator was the adaptive MCR digital platform, developed during the COVID-19 pandemic, enabling real-time monitoring, centralized, high-quality electronic medical records, timely e-CRF entry, and remote oversight of CT processes under extreme conditions. The system’s AI-assisted planning and multilingual tools are now being tested as a new paradigm for global CT continuity and effective performance. Conclusions: Armed conflict disrupts clinical research at every level, threatening patient safety, data integrity, and national research infrastructure. Our experience shows that rapid digital adaptation, operational flexibility, and collaborative governance can sustain oncology trials under extreme geopolitical conditions. These lessons offer a scalable framework for research continuity, regulatory alignment, and patient protection in conflict zones and disaster settings, reinforcing global oncology’s role in health system resilience and recovery.