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WORK PACKAGE ARCHITECTURE

WP1 — DATA HARMONISATION

Main aim: 

Create a central EU data registry for the harmonised collection of clinical data on patients treated with gene and cellular therapies from cells and tissues of hematopoietic origin to support collaborative studies and regulatory decision making.

Current status: 

High quality real world data from patients treated with cellular therapies is essential for monitoring safety and efficacy of these treatment as well as doing academic studies. Collecting this data is a time-consuming task for centres. To promote data quality and avoid a duplication of efforts, GoCART supports the notion ‘collect once, use often’.

Within this work package we work on a multi stakeholder revision of the EBMT cellular therapies data collection form. This is the standard data collection form that is used by the EBMT Registry. The data that is collected with this form supports collaborative studies as well as regulatory decision making. The main challenge is to balance the expectations of regulatory authorities and company requirements and the feasibility to collect RWD by centres. In Q1 2022 we meet again with all stakeholders to discuss the final draft form that incorporates the suggested changes from the stakeholders.