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Real-World Data: Electronic Record, Health Claims Data Guidance Gives Leeway On Validation

 
• By Sue Sutter

The selection of study variables and effort required for validation depends on the necessary level of certainty and the impact of potential misclassification on study inference, the US FDA’s final guidance says, a change from the September 2021 draft.

Electronic medical record
The FDA finalized guidance on assessing electronic medical records and claims data for regulatory use. • Source: Shutterstock

The US Food and Drug Administration’s final guidance on assessing electronic health records and medical claims data for regulatory use gives sponsors more leeway on issues related to study variable validation.

However, the final guidance does not appear to address some of industry’s other concerns about the September 2021 draft, including uncertainty on how drug sponsors and data providers can discuss plans for real-world evidence studies with the agency, as

Key Takeaways

  • The FDA’s final guidance on assessing electronic health records and medical claims data for regulatory use largely aligns with its September 2021 draft version.

  • However, the final document provides more leeway on issues related to validation of study variables, which some industry commenters requested

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