New EU guidance on registry-based studies

Written by | 13 Nov 2021 | Legislative and Regulatory

The European Medicines Agency (EMA) has published new guidance on generating evidence from patient registries. The publication aims to increase the quality of research using the wealth of data available from disease registries.

Patient registries collect uniform data over time on patients who are diagnosed with a particular disease or condition, or who receive particular medicines. A registry-based study is a clinical trial or a non-interventional study that investigates a research question using the data collection infrastructure or the patient population of one or several patient registries.

Medicine regulators may sometimes suggest that pharmaceutical companies use the data collection infrastructure or population of a patient registry to exploit information from clinical use and to monitor the safety and effectiveness of authorised medicines when used in the real-world setting.

There can be significant differences in requirements for types, structures and processing of data across existing registries. These can present challenges in the assessment of the suitability of existing registries to be used in clinical studies.

This guideline will facilitate a more data-driven, robust regulation of medicines, as foreseen in the Big Data Steering Group Workplan. It is based on a discussion paper on methodological and operational aspects for use in patient registries for regulatory purposes, which was available for public consultation and generated almost 1,000 comments from 68 stakeholder organisations. Input collected during five workshops on specific patient registries organised by the Agency also fed into the final guidance.

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