This facilitates data entry and data comparability. The standard data collection forms are used for the currently available CAR-T therapies and can also be used for many different CAR-T therapies in the future. Moreover, data collection is harmonised for all CAR-T therapies. Data won’t need to be reported to separate registries owned by the MAHs and EBMT, but only to the EBMT. The informal mantra of the EBMT Registry, ‘collect data once, use it often’, also applies to the CAR-T field. Moreover, we need data from all centres in Europe to be recorded in a central, academic registry to do meaningful analyses and to contribute to the global body of knowledge on CAR-T therapies. At a centre level, data reporting can contribute to improved patient management. It is important for EBMT to support these PAS studies and be in the lead of the Real-World Evidence generation on CAR-T therapies. This means that the normal EBMT Registry forms and data collection procedures are used to collect data in support of regulatory decision making on various CAR-T products. In 2019 the EMA issued a positive qualification opinion of the cellular therapy module of the EBMT Registry indicating that the Registry fulfills the essential needs to capture such data ( EMA’s qualification opinion ) and early 2020 the first PAS study protocols based on secondary use of EBMT Registry data were approved by the EMA’s Pharmacovigilance Risk Assessment Committee. These PAS studies are based on secondary use of EBMT Registry data.
The European Medicines Agency (EMA) obliges marketing authorisation holders (MAH, pharmaceutical companies) to conduct post authorisation safety (PAS) studies to monitor the long-term safety and efficacy of CAR-T therapies. However, the evidence on the long-term safety and efficacy of these treatments is limited. Transplant Complications Working Party (TCWP)ĬAR-T therapies are a very promising treatment option for many patients with haematological malignancies.Paediatric Diseases Working Party (PDWP).Infectious Diseases Working Party (IDWP).Chronic Malignancies Working Party (CMWP).Cellular Therapy & Immunobiology Working Party (CTIWP).Autoimmune Diseases Working Party (ADWP).Severe Aplastic Anaemia Working Party (SAAWP).Cellular Therapy Data Collection in Castor.
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