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As real-world data (RWD) and real-world evidence (RWE) continue to share the limelight in pharmacoepidemiologic and pharmacoeconomic journals and congresses, the demand for defining RWD and RWE as well as a framework for leveraging real-world research has never been greater.

One of the most pressing concerns involves what constitutes “regulatory grade” real-world data and real-world evidence, and when sponsors need to ensure that research conducted using data other than those generated via clinical trials meets the definition of regulatory grade.

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Clients I have worked with over the years have expressed concerns about regulatory grade everything: data (RWD), evidence (RWE), analytics, and submissions. Since the passage of the 21st Century Cures Act of 2016, the Food and Drug Administration has striven to provide definition and guidance around what is meant by real world. These are data and evidence deriving from health care records, claims and billing activities, or even from patients themselves. The FDA has done the same for what constitutes regulatory grade, which boils down to data sources that are relevant and reliable and research that is fully transparent and replicable.

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