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EMA Homes In On How To Improve RWD Quality

 
• By Neena Brizmohun

Draft guidance from the European Medicines Agency explores how data quality can impact the use of real-world data to generate real-world evidence for regulatory assessments.

Female engineer concept. GUI (Graphical User Interface).
New draft guidance explains how to assess and improve the quality of real-world data (Shutterstock)
Key Takeaways
  • Draft EU guidance on how to assess and improve the quality of real-world data (RWD) that is used for regulatory purposes is out for consultation until 31 January 2025.
  • The document focuses on the subset of RWD recorded within routine clinical practice and is intended to be used by the European medicines regulatory network, pharmaceutical companies and other stakeholders.
  • It includes practical recommendations on how to characterize the systems and processes that underpin data, and a set of metrics to assess data quality dimensions.


The European Medicines Agency is seeking feedback on draft guidance that aims to provide “actionable and focused recommendations” for assessing and improving the quality of real-world data (RWD) for regulatory...

The document, which is out for public consultation until 31 January 2025, discusses how data quality (DQ) can impact the use of RWD to generate real-world evidence (RWE) for regulatory...

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