Abstract
This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and 2018.
Publication types
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Evaluation Study
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Research Support, N.I.H., Extramural
MeSH terms
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Cross-Sectional Studies
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Data Science / methods*
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Drug Approval / legislation & jurisprudence
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Drug Approval / methods*
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Feasibility Studies
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Humans
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Pragmatic Clinical Trials as Topic / legislation & jurisprudence
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Pragmatic Clinical Trials as Topic / methods*
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Product Surveillance, Postmarketing / methods*
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United States
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United States Food and Drug Administration