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.
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.
