WORK PACKAGE ARCHITECTURE

Context:

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.

Overall aim: 

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