Real-World Evidence — Where Are We Now?

Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.

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Bibliographische Detailangaben
Veröffentlicht in:	The New England journal of medicine 2022-05, Vol.386 (18), p.1680-1682
Hauptverfasser:	Concato, John, Corrigan-Curay, Jacqueline
Format:	Artikel
Sprache:	eng
Schlagworte:	and the FDA Clinical Medicine Clinical Medicine General Comparative Effectiveness COVID-19 Devices Drugs Electronic health records FDA approval Health Policy Product development
Online-Zugang:	Volltext
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Beschreibung
Zusammenfassung:	Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMp2200089