EMA Offers Suggestions for Improving Patient Registry Use in CAR T-cell Evaluations

The European Medicines Agency issued a report with recommendations for improving the use of patient registries in benefit-risk evaluations of chimeric antigen receptor T-cell (CAR T-cell) therapies.

The recommendations included comments the agency received at a stakeholder workshop in February. The workshop explored the challenges and payoffs of using existing registries to support benefit-risk evaluations for CAR T-cell therapies and post-authorization follow-up, and discussions were held regarding registry governance, patient consent, data sharing and quality, registry interoperability and core common data needed by stakeholders.

The report suggests establishing arrangements that permit data sharing and improved communications among applicants, registry holders, marketing authorization holders and regulators.