EBMT data collection initiative on IEC therapies
Research type
Research Study
Full title
Data collection initiative on IEC therapies, based on secondary use of data
IRAS ID
285530
Contact name
Andrea Kuhnl
Contact email
Sponsor organisation
EBMT
Duration of Study in the UK
20 years, 0 months, 31 days
Research summary
Patients receiving IEC (Immune Effector Cell) therapy are invited to participate in the EBMT Registry by EBMT member physicians. Data from routine clinic visits is collected on the disease, treatment and outcome, including complications. The data is collected electronically using standardised forms and is stored in a certified and secure database in the European Union. These data will be shared with Marketing Authorisation Holders (MAHs), that need to monitor the long-term safety and efficacy of their product for regulatory purposes. The European Medicines Agency qualified the Cellular and Gene Therapy Form of the EBMT and recommends MAHs to conduct their post-authorisation studies on CAR T-cell therapy using data captured in the EBMT Registry.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0001
Date of REC Opinion
4 Feb 2021
REC opinion
Favourable Opinion