The brazilian registry of hematopoietic cell transplantation and cellular therapy: A MODEL of collaborative progress and DATA management leadership

Abstract

Abstract Background: The establishment of the Brazilian Registry of Hematopoietic Cell Transplantation and Cellular Therapy (RBTCH-TC) in 2019, through collaboration between the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) and the Center for International Blood and Marrow Transplant Research (CIBMTR), aimed to consolidate national data and enhance multicenter research. Alongside the registry, the SBTMO created the Data Managers Working Group (GTGD-SBTMO) to develop national standards, ensure data quality, and promote safe and effective cellular therapies (CT), including Hematopoietic Cell Transplant (HCT) and CAR-T cell therapy (CAR-CT). Methods: A historical, documentary, and experience-based review was conducted, drawing on official records, collaborative projects, training initiatives, and database activities related to both the RBTCH-TC and the GTGD-SBTMO. Results: From 2016 to 2024, the number of Brazilian centers actively reporting to the CIBMTR grew by 191% (from 11 to 32), and registered HCT procedures increased by 204% (from 628 to 1,909). The multicenter study (CAAE 65575317.5.1001.0071) currently includes 90 centers authorized by the National Ethics Commission, with 60 centers approved by local ethics committees. The 2025 Summary Slides consolidate 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 inception, the GTGD-SBTMO has developed a mission, a vision, and operational (administrative, scientific, educational, etc.) subcommittees, adopting tools such as Trello and AI meeting minute generators. It has organized 59 training events, with a 4.9/5 satisfaction rate, and has led the standardization of data submissions to the 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, with an English version to come. In 2024, 71 database queries were logged, 82% of which by physicians, with a 92% resolution rate; 63% supported scientific meeting submissions. Conclusion: The RBTCH-TC and GTGD-SBTMO symbolize a successful, regulation-based model of collaborative data management and registry development in cellular therapy. Their integrated efforts have improved data quality, research capacity, and national coordination, with a direct impact on public health policy, clinical outcomes, and international collaboration. Continued investment in training, infrastructure, and adaptive strategies is essential to sustain and expand the progress achieved.