Navigating the Planning and Initiation of a First Prospective Clinical Trial Through a Regional Pediatric Oncology Consortium Within the Middle East, Africa, and Asia—A Roadmap

Background: Prospective pediatric oncology clinical trials remain scarce across low- and middle-income countries (LMICs). We developed the first multicountry prospective clinical trial within the Pediatric Oncology East and Mediterranean (POEM) group. Localized osteosarcoma was selected due to heterogeneous real-world management, including alternative regimens in settings where methotrexate administration is not feasible. This descriptive report details the feasibility of a regionally coordinated, resource-adapted clinical trial across diverse LMIC settings. Methods: We describe the planning, capacity assessment, training, governance, and activation of POEM-OS, a pragmatic two-arm prospective cohort study evaluating MAP- and OS99-based therapy for localized osteosarcoma. Preparation included a structured capacity-mapping exercise across regional centers to assess clinical resources, research, and regulatory structures. The approach also encompassed designing a training program and communication through a structured study coordination team. Results: A total of 27 centers from 10 countries expressed intent to participate. A 12-week virtual training curriculum was implemented for principal investigator and clinical research coordinator dyads, followed by an in-person regional workshop. Eventually, 21 centers (8 countries) proceeded to study activation. Major barriers included heterogeneity in chemotherapy administration, high staff turnover, and variability in timelines to study-agreement execution. Adaptive solutions included permanently accessible online training modules, simplified chemotherapy dosing, and harmonized toxicity grading. Centralized REDCap platforms enabled regional data sharing. By February 2026, the study had opened at 16 centers, with 21 patients enrolled. Conclusion: POEM-OS demonstrates that a regionally directed, resource-adapted clinical trial platform is feasible across diverse LMIC settings and establishes a foundation for sustainable regional clinical research infrastructure.