Establishment of a Cellular Therapy Registry in Japan, a platform for data sharing for research, industry, and regulatory use

抄録

 The recent approvals of new cellular immunotherapy (CI) agents requiring long-term followup to monitor safety and efficacy outcomes calls for rapid implementation of a monitoring system. A standardized outcomes database is one solution. The three Hematopoietic Cell Transplantation (HCT) registries of the Center for International Blood and Marrow Transplant Research (CIBMTR), European Society for Blood and Marrow Transplantation (EBMT), and the Japanese Society for Transplant and Cellular Therapy/Japanese Data Center for Hematopoietic Cell Transplantation (JSTCT/JDCHCT) undertook a project to harmonize CI survey items in 2016, establishing a collaboration between the JSTCT/JDCHCT and CIBMTR to leverage existing resources to develop and maintain a data collection structure to handle data from acquisition through processing. This process culminated in the development of a shared patient registry for research on, as well as post-marketing surveys of, treatments in Japan. The initial focus was on CD19-targeted CAR-T cells, the first commercial product of its kind approved in Japan. All Japanese centers were connected to the registry in 2020. Patient registries consist of real-world data, providing a model for their regulatory use. The collaboration addresses technical barriers to international data sharing, allowing worldwide data utilization by academia, industry, and government.