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EMA - Guideline on registry-based studies

29th September 2020

EMA has published its draft Guideline on registry-based studies for a three-month public consultation. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence.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. Registry-based study is an investigation of a research question or hypothesis using data from (a) new or existing registry(-ies) for patient recruitment and data collection. A registry-based study may be a clinical trial or a non-interventional trial/study. 

Studies based on patient registries generate real-world evidence that can complement the knowledge gained through pre-clinical studies and clinical trials during the development of a medicine. Studies derived from patient registries can also provide information that is critical to understanding the benefits and risks of medicines in everyday use by patients and healthcare professionals.

The guideline addresses methodological, legal and operational aspects in the use of registry-based studies to support regulatory decision-making. It focuses on studies based on disease registries or condition registries (i.e. registries characterised by the presence or occurrence of a particular disease, disease-related patient characteristic or a specific condition) to examine the use, safety and effectiveness of medicines prescribed to or consumed by patients included in the registry. The guideline also outlines key regulatory considerations related to the establishment and management of patient registries, which are important for their use in registry-based studies.

Stakeholders are invited to send their comments via an online form by 31 December 2020

Following the public consultation, comments from stakeholders will be analysed and considered in the final document that will be published in 2021.

As part of the consultation process, EMA is hosting a virtual workshop on 19 October 2020 to present the draft guideline to key stakeholders. The workshop provides an opportunity to discuss questions, perspectives on the usefulness of the document and recent experience on methodological aspects of registry-based studies. The meeting can be followed via live broadcast on the event page.

For more details, please click here.

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