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WORK PACKAGE ARCHITECTURE
In Europe, clinical data from patients treated with gene and cellular therapies are reported to many registries, each built for a limited purpose, with different governance rules and specific software tools managing the data. This results in siloed data, inefficiencies and duplication of efforts.
Create a central EU data registry for the harmonised collection of clinical data on patients treated with cellular therapies to support collaborative studies and regulatory decision making.
Current work groups/activities:
- Review and update the EBMT Cellular Therapy form
- Align with CIBMTR to create a common data set and harmonised definitions for gene and cellular therapies, alignment with other registries could also be assessed;
- Develop a harmonised gene therapy form