At the first Registry Annual Data Management Educational Event (10-11 November 2021), the registry team presented a new database for cellular therapy, called Castor.
Since EBMT discontinued the development of Macro and cell therapy data collection possibilities in ProMISe are unsatisfactory, an alternative method of collecting cell therapy data was necessary.
The current ProMISe cellular therapy form holds only a small fraction of the items that are relevant for cellular therapies. The implemented form dates from 2018, and an update is necessary. Particularly the data that is important for the Post-Authorisation Safety and efficacy Studies (PAS) cannot be entered into ProMISe sufficiently at this moment.
As the availability of ProMISe ends soon and finding a replacement is a time-consuming process, the decision was made to use Castor. Castor is a data management platform used by various institutes to perform clinical studies. It conforms to all international regulations regarding data safety (ISO 27001, GDPR).
What does this mean for your center?
Centers still enter the diagnosis, HSCT, and pre-treatment information in ProMISe. To do this, instruction documents will be provided. Cell therapy, the infusion unit, infusion episode and follow-up including complications and infections will be entered into Castor.
Frequently asked questions
Will the cellular therapy form be updated?
Yes, the registry team is currently working on a new version of the cellular therapy form. Once this is finalized, it will be put on the EBMT website together with an updated manual.
Will there be more training sessions for data managers?
No, however a Castor guide will be put on the EBMT website and the videos from the educational event will be made available as well. Castor itself has training videos available on: https://academy.castoredc.com/ . A special helpdesk for cellular therapy related questions will be developed to support data entry. This page will be updated once the helpdesk is set up.
Our center downloads data from ProMISe for analyses. Is that functionality available in Castor?
Yes, you will be able to export all the data related to your center in xlsx-, csv- and sav format, selecting which variables or sections of the study you need. All these details will be explained in the manual.
In the Q&A it was mentioned that there is no training database available for cellular therapy. How can we practice working with the system?
When you first access Castor, you will see that by default you have access to a template study. It is a study totally unrelated to Cellular Therapy but allows one to freely play with Castor as a system. Furthermore, there is Castor Academy where you can watch free training videos of Castor: https://academy.castoredc.com/ .
How can I get an account for Castor?
When the database is finished, you will receive an invitation with instructions. Creating an account will also be explained in the Castor manual.
When will the Castor manual be available?
The manual will be ready once the form revisions are finished. Castor needs to be ready to go before those manuals are shared, to ensure that all information there is up to date.
Will the database structure in ProMISe be changed?
No, nothing will be changed in ProMISe.
Will the CAR-T data that is in ProMISe be transferred to Castor?
Patients for whom informed consent data is available will be transferred to Castor. The consent question will be mandatory for Castor. However, there are quite a few instances where the consent registration in ProMISe is missing so it would be hard to determine if that consent is given or not. We are looking into how to solve this.
From the instruction videos, it appears that only one bacterial or fungal infection can be entered into Castor. What if a patient had multiple infections?
At the moment, Castor implementation follows the new Cellular Therapy paper forms.
In Castor you can select as many complications/infections as needed, but only one instance of each complication/infection. We have received numerous comments regarding this and we are exploring the possibility to register more than one event of each kind per time period.
Does Castor save automatically?
Yes, Castor saves after every completed field.
After how long of inactivity does the system log you out?
A session in Castor EDC automatically expires after 20 minutes of inactivity.