Background: Pediatric Neurology and Trial Overview
Allucent was selected to perform a Phase III study to investigate the safety and efficacy in treatment of a neurological condition in pediatric patients with close to 20 sites in various locations, including Eastern Europe.
Services: Project Management, Clinical Operations and Monitoring, Medical Writing for Informed Consent Form (ICF), Pharmacovigilance, Medical Monitoring
Challenges in Patient Recruitment and Site Replacement Strategy
Following the escalation of conflict between Russia and Ukraine, the sponsor made the strategic decision to exclude Russian sites from the study after the initial start-up phase. This unexpected loss of three sites in a critical location led to delays in site activation and patient enrollment, as new countries and sites had to be identified and initiated under urgent timelines.
At the same time, sites located in Ukraine faced significant operational and safety challenges due to the ongoing war. Despite the volatility, Ukraine remained a critical participant in the study given its status as a top-recruiting region. However, maintaining Ukrainian site involvement introduced complex considerations around staff and patient safety, logistical continuity, and potential disruptions to clinical supply shipments.
Solutions in Action: Strategic Site Replacement & Remote Monitoring Innovations
In response to the decision to exclude Russian sites, the sponsor requested an additional feasibility assessment to identify alternative sites in other countries. Allucent responded swiftly and strategically, conducting a thorough multifactorial assessment that considered the study design, targeted patient population, the recent operational performance, and standard of care across potential sites. Based on this analysis, our team developed a tailored country and site strategy that aligned with the sponsor’s corporate objectives and unique requirements of the trial.
To expedite site qualification while maintaining rigor, Remote Site Evaluation Visits (RSEVs) were conducted using a fully virtual, technology-enabled approach. These evaluations leveraged secure digital platforms for live facility tours, real-time documentation review, and collaborative discussion with site staff. This remote format allowed us to rapidly assess sites’ capabilities without the delays associated with travel and on-site coordination. As a result, eight additional sites were approved, restoring study momentum and minimizing enrollment delays through a flexible and innovation-driven process.
Allucent’s project management and clinical operations teams partnered closely with principal investigators in Ukraine to ensure uninterrupted patient care. Recognizing the potential for additional strain on site resources and staff, our teams implemented targeted site engagement strategies that included frequent check-ins tailored to site preferences, expedited communication channels for urgent issues, and the provision of logistical and emotional support to address emerging site-level concerns.
Through compassionate and consistent support at each visit, the teams reinforced site engagement and helped sustain patient participation during an exceptionally uncertain time. Customized guidance, flexible visit planning, and on-demand clinical support helped alleviate pressure on sites and ensured protocol compliance even in unpredictable conditions. These engagement efforts were instrumental in sustaining patient participation, minimizing protocol deviations, and maintaining data integrity. The dedication of Ukrainian site staff played a pivotal role in preserving study continuity and patient safety.
To safeguard clinical research associates (CRAs) operating in Ukraine, Allucent implemented a Remote Monitoring Plan for Ukraine that utilized a secure, restricted remote SDV platform. The rapid inclusion of this technology allowed for continued oversight of data quality and compliance while prioritizing staff safety.
Demonstrating its commitment as a proactive partner, Allucent also identified a local depot and central laboratory within Ukraine. This localized solution mitigated potential shipping disruptions, ensuring timely delivery of study supplies and lab samples despite the ongoing conflict.
Outcome: Accelerated Enrollment for Pediatric Neurology Study
Despite the uncertainty and delays that began at study start-up and persisted throughout the enrollment process, Allucent’s nimble, decentralized approach to site activation and management, patient recruitment and engagement, and remote site monitoring strategies ensured that the study was able to swiftly adapt, and enrollment was completed one month ahead of schedule.
To learn more about our patient recruitment and site management solutions, visit Patient Recruitment & Retention.
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