THE BRAZILIAN REGISTRY OF HEMATOPOIETIC CELL TRANSPLANTATION AND CELLULAR THERAPY: A MODEL FOR COLLABORATIVE ADVANCEMENT AND DATA MANAGEMENT

Establishment in 2019 through a strategic collaboration between the Brazilian Society of Bone Marrow Transplantation and Cellular Therapy (SBTMO) and the Center for International Blood and Marrow Transplant Research (CIBMTR), the Brazilian Registry of Hematopoietic Cell Transplantation and Cellular Therapy was designed to consolidate national data and foster multicenter clinical research. Concurrently, SBTMO created the Data Managers Working Group (GTGD-SBTMO) to develop national standards, ensure data quality, and support safe and effective cellular therapies (CT), including Hematopoietic Cell Transplants (HCT) and CAR-T cell therapies (CAR-CT). To describe the development and impact of the Brazilian Registry of Hematopoietic Cell Transplantation and Cellular Therapy (RBTCH-TC) and the GTGD-SBTMO, focusing on their strategies to expand national reporting capacity, standardize data collection, and strengthen research infrastructure for HCT and CAR-T therapies in Brazil. A comprehensive historical and documentary review was performed, incorporating institutional records, collaborative projects, training initiatives, and database activities related to both RBTCH-TC and the GTGD-SBTMO. Between 2016 to 2024, the number of Brazilian centers actively reporting data to the CIBMTR increased by 191% (from 11 to 32), while reported HCT procedures rose by 204% (from 628 to 1,909). The ongoing multicenter study (CAAE 65575317.5.1001.0071) comprises 90 centers authorized by the National Ethics Commission, with 60 centers approved by their respective institutional review boards. The 2025 summary slide consolidates data from 14,331 transplants across 45 centers (2012–2024). The CT section includes 11 centers, 104 CAR-T cell infusions, and two published summary slides (2024 and 2025). To support growing data demands, 95 analysis requests have been recorded through an established request workflow. Since its formation, GTGD-SBTMO developed a mission, vision, and operational subcommittees (administrative, scientific, educational, etc.), adopting tools like Trello and AI-assisted minute generation. It has organized 59 training events with a 4.9/5 satisfaction rate and led the standardization of data submissions to CIBMTR, expanding reporting centers from 10 to 92. The group has published 7 scientific papers (5 on HCT, 2 on CAR-CT), created a "Knowledge Trail for Data Managers," and released a Data Management Guide, also available in Spanish. In 2024, 71 database queries were logged 82% from physicians with a 92% resolution rate; 63% supported abstract submissions to scientific conferences. The RBTCH-TC and GTGD-SBTMO represent a robust and scalable model for collaborative registry development and data governance in cellular therapy. Their coordinated efforts have significantly enhanced data integrity, research capacity, and national integration, contributing to improved clinical outcomes, public health policymaking, and international collaboration. Sustained investment in digital infrastructure, human resource development, and adaptive strategies will be critical to maintaining and expanding these achievements.