EMA has published its draft Guideline on registry-based studies for a three-month public consultation today. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence.
Patient registries are databases containing quantitative and qualitative data about patients who are affected by a particular condition.
The guideline addresses methodological, legal and operational aspects in the use of registry-based studies to support regulatory decision-making.
Stakeholders are invited to send their comments via an online form by 31 December 2020.
Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.