Opinion: STAT+: The need for regulatory grade evidence: Are you in the stadium or the sandbox?
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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