EBMT NEWSLETTER | July 2018 | Volume 61 - Issue 2

EBMT Registry Upgrade

As 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:  
  • The completion of essential software developments has been delayed by three months. In particular, the extension of querying and reporting tools have not been fully developed and tested.
  • As a consequence, training materials have not been completed nor have training schedules developed beyond a strategic level. Both the EBMT and the national registries are concerned that there will not be sufficient time to deploy a good training program if we go live in November.
  • Data migration is progressing more slowly than expected, and we cannot guarantee that it be properly validated before the original November go-live date.
In addition, we have received feedback from some national registries expressing concern that a go-live close to the end of the year might disrupt the production of annual reports.  For all these reasons, we have now settled upon early February 2019 for the go-live date.  

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 development

The 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 Manager

Our 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.

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