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

GoCART held a number of multi-stakeholder meetings in 2020 to 2022 to review the EBMT cellular therapy form to ensure that it is up to date with latest developments in the field. The first key changes were implemented in 2022. All EBMT data collection forms will undergo an annual renewal process and GoCART will convene stakeholders in 2024 to discuss the next proposed changes to the cellular therapy form and other related EBMT Working Party forms.

GoCART is collaborating with the T2Evolve consortium to develop a harmonised European parameter set and core data structure for the evaluation of CAR T-Cell therapies (CART-CD). We will do this by involving experts across major European institutions and study groups in a Delphi process to systematically  establish 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. To start the process, we held a joint workshop on “Data accessibility, comparability and shareability” at the CART2024 meeting in Valencia to reach consensus and develop next steps. We have identified the experts to develop the questions for the Delphi process. We are now developing the expert panel to answer the questions – please contact us if you are interested in taking part.