See below the full texts relating to: the Informed Consent Form, the agreements, Data reporting and Registry update. Read on.
Informed Consent Form
The adapted consent form allows patient level data to be shared with MAHs and the EMA for the sole purpose of supporting PAS studies and ultimately, regulatory decision making.
Data collection for the EBMT registry is currently done using the standard informed consent form. This allows EBMT to share aggregate, anonymous data with MAHs. However, to evaluate the safety and efficacy of the CAR T-cell therapies, the EMA requires patient level data with batch numbers for the treatments. The processing of this pseudonymised data is governed by the GDPR and requires patient consent.
To this purpose, EBMT has amended its patient consent form to allow patient level data to be shared with MAHs and the EMA, for the sole purpose of supporting PAS studies and ultimately, regulatory decision making. This means that there will be no separate informed consent forms for individual PAS studies, but a general informed consent form that can be used to support PAS studies currently available as well as future CAR T-cell therapies.
Until the updated informed consent form is approved and the patient has reconsented, data will be shared only in aggregate reports.
To participate in the data collection initiative a centre must sign the Data Collection Master Agreement and a Product Specific Agreement. In addition, all EBMT centres should signa Joint Controllership Agreement.
The contracts for the data collection initiative on CAR T-cells are split in two parts. The Data Collection Master Agreement governs the general data collection requirements that are identical for all CAR T-cell therapies. Whereas the short Product Specific Agreements specify additional requirements for the individual CAR T-cell therapies. For each new PAS study you will only need to sign a new Product Specific Agreement.
We also remind your centre to sign the Joint Controllership Agreement (JCA), which stipulates that all data processing is done in compliance with the GDPR. This document governs all data processing activities between EBMT and the centre and is thus a prerequisite but not specific for the PAS studies. The JCA should be signed by all centres, including those who do not participate in the data collection initiative on patients treated with CAR T-cells.
Report data on all patients treated with CAR T-cell therapy within one month of treatment or the follow up visits.
Data collection per the regular data collection forms and procedures does not require additional contracts and regulatory approvals. We thus ask you to report data on all patients treated with CAR T-cell therapy within one month of treatment or the follow up visits which are expected around day 100, 6 months and then yearly for 15 years.
While the efforts to update the Registry system ProMISe are ongoing, we ask you to continue reporting data on patients with CAR T-cell therapies.
As many of you know, EBMT is updating its Registry system ProMISe. This update also impacts the collection of CAR T-cell data. To ensure all relevant data is collected to support regulatory decision making as well as our scientific activities, the ‘Cellular Therapy Form’ as currently available in ProMISe- is being updated to include more detailed information on e.g. comorbidities and complications. Until the update has been finalised in the database we periodically request you to provide this data by means of data requests.
If you have any questions about data reporting for the data collection initiative, please contact the Clinical Study Unit by sending a mail to: EBMT_NK01@lumc.nl