EMA - draft reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence

7th May 2024

The EMA are pleased to inform you about the publication of a draft reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence, which is now open for public consultation.  The reflection paper discusses methodological and data quality aspects of non-interventional studies using real-world data to generate real-world evidence for regulatory purposes.
 
All interested partners and stakeholders involved in the planning, conduct and analysis of non-interventional studies using real-world data are invited to provide feedback on the draft reflection paper. The public consultation is open until 31 August 2024.
 
During the public consultation, the reflection paper will be presented and discussed to gather initial feedback in a dedicated session at the multi-stakeholder joint HMA-EMA workshop on RWE methods on 14 June 2024: https://www.ema.europa.eu/en/events/joint-hma-ema-big-data-steering-group-workshop-rwe-methods
 
The development of this reflection paper is part of the Methodology Working Party Workplan 2022-2024 and the joint HMA-EMA Big Data Steering Group plan 2023-2025. It addresses goals related to the real-world evidence guidance development.
 
The draft document is available at the following link: https://www.ema.europa.eu/en/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence-scientific-guideline

Any questions on the reflection paper, please email MWP@ema.europa.eu
 

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