EMA explores making better use of patient registries to support drug evaluation

The European Medicines Agency is looking at ways to make better use of existing patient registries - and help set-up new ones where needed - to generate additional data for the benefit-risk evaluation of medicines1. The project involves exploring, among other things, whether a registry can be used simultaneously to support both regulatory and health technology assessments.

The current approach to patient registries is sometimes "suboptimal" in scientific and resource terms as there is lack of: common protocols, scientific methods and data structures; data sharing and transparency;...