EMA Defines Actions For Using CAR-T Registries For Regulatory Evaluation

A multi-stakeholder EU workshop has helped identify how patient registries can support the benefit-risk evaluation of CAR-T cell therapies, given the challenges posed by these products, not least the need for the long-term follow up of treated patients.

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Registries Can Help Generate Post-Market Data On CAR-T Therapies • Source: Shutterstock

The European Medicines Agency has issued several recommendations to help facilitate and improve the use of patient registry data to support the evaluation of chimeric antigen receptor T-cell (CAR T-cell) therapies.

The recommendations, which include introducing a method for the systematic collection of a set of core commonly-defined data elements, follow...

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