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EMA Publishes Guidance to Provide Key Methods and Good Regulatory Practices on the Planning and Conduct of Registry-Based Studies

The European Medicines Agency (EMA) published on 26 October 2021 the guideline on registry-based studies. This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support regulatory decision-making.

It aims to help with defining study populations and designing study protocols. It provides guidance on data collection, data quality management and data analysis to achieve higher quality evidence.

The guideline focuses on studies involving disease registries or condition registries to evaluate the benefit-risk of medicines prescribed to or consumed by patients. It explains the methodological differences between these types of studies and registries.

It also contains an annex with good practices in the establishment and management of patient registries and their use for other possible regulatory purposes.

A patient registry is an organised system that collects 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 often present challenges in the assessment of the suitability of existing registries to be used in clinical studies.

This guideline aims to help those involved in registry-based studies to better define study populations and design study protocols; it provides further guidance on data collection, data quality management and data analysis to achieve higher quality evidence. This in turn will facilitate EU regulators’ assessment of the safety and effectiveness of medicines, for the benefit of public health.

As patient registries are key to conducting registry-based studies, the guidance includes an annex with good practices in the establishment and management of patient registries and their use for other regulatory purposes.

This guideline will facilitate a more data-driven, robust regulation of medicines, as foreseen in the Big Data Steering Group Workplan that implements the Network Strategy to 2025. 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. Experience gained from EMA’s Committee for Medicinal Products for Human Use qualification opinions for two networks of registries, and input collected during five workshops on specific patient registries organised by the Agency also fed into the final guidance.

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