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Operational Burden and Fragmented Implementation in CAR T-cell Therapy: Insights from a Multinational Survey by the GoCART Coalition and the JACIE Quality Managers Committee.

by
Research
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Quality Managers Committee
GoCART Coalition

As part of its 2024 initiatives, the JACIE Quality Managers Committee (QMC) developed a survey aimed at hospitals to identify the logistical and organisational challenges, as well as the inspection burden, associated with the CAR-T process. The initial findings were presented at the 51st Annual Meeting of the EBMT in March 2025.

In collaboration with the GoCART Coalition, the EBMT, and dedicated contributors from hospitals including UMC Cologne, Radboud UMC Nijmegen, UMC Utrecht, and the Catharina Hospital in Eindhoven, the JACIE QMC has successfully translated these results into a scientific publication in HemaSphere.

The paper is based on a survey conducted in January 2025 among hospitals across Europe and beyond, yielding responses from 146 institutions. Through this work, we aim to raise awareness of the cumulative impact of multiple inspections addressing the same processes within haematology departments. It is hoped that this will encourage CAR-T manufacturing companies to engage more closely with healthcare organisations and JACIE, in order to streamline inspection procedures, reduce redundancy, and maintain the highest standards of quality and patient care.