Randomized noninferiority trial assessing biobanking capacity in LMICs, highlighting collaboration and regulations.
10023 Background: Biobanks advance translational research in pediatric oncology. Understanding the existing biobanking infrastructure is critical for fostering collaboration and improving research capacity in low- and middle-income countries (LMICs). Methods: A previous research capacity survey within institutions of the Pediatric Oncology East and Mediterranean (POEM) Group collaborative network identified 26 out of 69 institutions across 23 countries, with access to clinical tissue specimens for research use. We surveyed these centers regarding sample/data management, patient population, governance, standard operating procedures (SOPs), quality systems, and funding. This study was determined non-human subjects research by the Stanford IRB. Biobanking capacity and participation were evaluated using descriptive statistics (medians, ranges, and frequencies). Results: Fifteen of the 26 (58%) institutions confirmed that they have a research-specific biobank; 10 of 15 (67%) participated. All surveyed biobanks collect cancer samples using broad consent, and have ongoing funding through institutional support, external collaborations or both. Principal investigators lead 20% of the biobanks, the others are institution-based and led. A median of 7 staff are involved in biobanking activities per institution (range, 3–28). Most institutions (80%) rely on Microsoft Excel for sample tracking. A quality management system is implemented in 7 of 10 (70%) of institutions, with most adhering to ISBER best practices. Five of 10 (50%) of the biobanks lack disaster management SOPs. Eight of 10 (80%) biobanks are capable of sharing samples and associated clinical data with other institutions through material/data sharing agreements. A median of 3500 samples (range, 368–6000) are stored yearly with a median of 300 samples (range, 100–1000) released for authorized research. While most biobanks viewed their national legal frameworks as supportive, 2 biobanks (20%) indicated that national regulations constrain biobanking activities. All the respondents indicated a need to improve their national regulation to support ethical biobanking practices – specifically need for improved regulation for cross-border collaborations, data privacy, and intellectual property (60%, 40% and 30%, respectively). Conclusions: Biobanks exist in 21.7% (15 of 69) centers within the POEM group. Biobanks in the region have robust consenting and sample collection procedures. Significant opportunities exist to enhance capacity through implementation of international quality standards, and improved disaster preparedness. Further understanding of the determinants of successful initiation and maintenance of these biobanking efforts in LMICs will guide targeted initiatives to further expand regional biobanking infrastructure and augment research collaborations.
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Srinivasan et al. (2026) studied this question.
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