Managing Multi-Source Data in Global Oncology Trials: Operational and Data Quality Insights From the COST-FIN Trial
Zainab Adegbite, Clement Awe, Toluwanimi Aduloju, Chinenye Iwuji, Dorcas Ebekue, Opeyemi Akinlusi, Josephine Adeyeye, Oluchi Adewole, Funmilola Wuraola, Fatimah Abdulkareem, Adedayo Joseph, Lisa Hirschhorn, Juliet LumatiPURPOSE
Successful implementation of global oncology clinical trials in low- and middle-income countries requires strong operational systems, including research assistants (RAs), centralized data quality oversight, and coordinated multi-site management. COST-FIN is a pragmatic randomized controlled trial evaluating whether structured financial navigation (FN) reduces financial catastrophe, financial distress, and cost-related treatment non-adherence among adults with newly diagnosed breast, colorectal, or prostate cancer in Nigeria. This analysis describes the staffing, data quality, and coordination infrastructure needed to implement COST-FIN across Nigerian oncology sites.
METHODS
We conducted a mixed-methods evaluation of operational experiences within COST-FIN. Seven RAs across three sites conducted screening, enrollment, and longitudinal follow-up. Data collection included structured interviews, medical record abstraction, and patient receipts, captured through electronic and paper-based systems and reconciled into a centralized database. A dedicated data quality manager oversaw validation, discrepancy resolution, and receipt-level data integration through an individual receipt submission workflow. In-country coordination was led by a Nigeria-based project manager with a U.S.-based trial coordinator. Data sources included workload logs, data quality reports, and qualitative feedback from RAs and leadership.
RESULTS
Between July 2024 and April 2026, 1,200 patients were screened, and 220 were enrolled. The RA team supported enrollment and follow-up across multiple institutions while managing high- volume, multi-source data. Operational workload included processing and verifying more than 4,000 patient receipts, along with baseline and follow-up assessments. Over 22 months, RAs contributed an estimated 24,160 hours across enrollment, follow-up, and data management, while centralized data quality oversight required more than 500 hours. RAs integrated clinical, interview, and financial data, requiring continuous reconciliation of paper and electronic records. Centralized oversight supported systematic discrepancy resolution, data completeness, and audit readiness. The Nigeria-based project manager facilitated real-time site coordination and linked local teams with international leadership. Qualitative findings highlighted the time-intensive nature of financial data verification and the importance of layered coordination structures.
CONCLUSION
Large-scale global oncology trials in resource-limited settings require sustained investment in frontline research staff, centralized data systems, and multi-level coordination. Within COST- FIN, RAs, data quality oversight, and in-country project management were essential to trial operations, financial data integrity, and cross-site implementation fidelity.