EBMT Registry UpgradeAs many members are aware, the EBMT is upgrading the current registry system onto a new platform MACRO. The development has been underway since March 2017 and significant progress has been made. The development is going well. Nevertheless we are facing a slight delay for the following reasons:
We appreciate your continued support for the Registry upgrade and look forward to your assistance in achieving the new go-live date. Please be in no doubt of our commitment to delivering the best EBMT Registry, fit for present and future needs.
Should you have any questions or comments about the projects please direct them to Nigel.Brook@ebmt.org.
Database and forms under developmentThe small team at the Registry Office in London (along with study coordinators in the Paris & Leiden Offices) are continuing to test the MED-AB design in the upcoming new system: MACRO. We also have several external volunteers who are helping out as beta testers. We would like to thank the centre data managers and the national registries who are involved in the beta testing of Data Entry and the system overall. They are providing valuable feedback and testing time. The Data Retrieval function should soon be delivered by MACRO for testing. Information on training will follow at a later date.
The MED-B data collection forms require of restructuring for MACRO compatibility. The Registry team is currently engaged in doing so with support from the different Working Parties.
Cell Therapy is also being taken into consideration. The EBMT participated in the “ CAR T Cell Therapy Registry Workshop “ organised by the European Medicines Agency (EMA Committee for Advanced Therapies) in February 2018. One of the outcomes of the workshop was a consensus on relevant items necessary to follow patient outcome after CAR T-cell treatment. The Registry has revised the EBMT’s cell therapy form against those items and the revised form is being shared with the EMA.
In addition, on June 29, the EMA released its draft qualification opinion on using the EBMT registry to support CAR T-cell therapy post-authorisation follow-up and risk-benefit evaluations. For more information, please read this article.
Appointment of Registry Operational ManagerOur Head of Registry, Carmen Ruiz de Elvira, will be retiring in November 2019. We are seeking to appoint a Registry Operational Manager at the end of 2018 because we envisage a reasonable handover period and we would like the suitable candidate to work alongside Carmen for approximately 1 year. If this may be of interest please see the advertisement for this post, which will be based at Guy’s Hospital in London.