Data challenges for externally controlled trials: viewpoint

HIGHLIGHTS

SUMMARY

    Historically, real-world evidence from observational studies has had limited use for demonstrating therapeutic effectiveness for regulatory and reimbursement purposes. Several recent developments, including the 21st Century Cure Act, increased accessibility to large-scale routinely collected health data, improved standardization of collection, and increased high-profile regulatory applications, and have resulted in an increased demand for these data and increased availability of these data. Real-world data are data related to patient health status or delivery of health care outside of RCTs where sources commonly originate from electronic health records (EHRs), medical claims data . . .

     

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