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WORK PACKAGE ARCHITECTURE

DATA HARMONISATION

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 the Center for International Blood and Marrow Transplant Research (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.

Main achievements to date:

  • A number of multi-stakeholder meetings were held to review the EBMT cellular therapy form to ensure it is up to date with  latest developments in the field. The first key changes were implemented in 2022 and have been included in the form used for the new EBMT registry in 2023. Additional yet-not-implemented fields will become part of the annual renewal process of updating the form. The process of upcoming changes will be discussed with all stakeholders and implemented in 2024. 
  • GoCART has started a collaboration with the T2Evolve consortium to develop a harmonised European parameter set and data structure for the evaluation of CAR-T therapies. We will do this by involving experts across major European institutions and study groups in a Delphi process to establish systematically a minimal core/required parameter set (‘must have’) with additional expansion modules that capture extended clinical parameter sets and biological features for special clinical and/or biological purposes.