Communication of Survival Data in US Food and Drug Administration–Approved Labeling of Cancer Drugs

Naci et al examine how information on overall survival benefits of novel cancer drug indications is communicated in labeling. Overall survival (OS) - how long patients live after treatment - is arguably the most definitive patient-relevant outcome when evaluating cancer drugs in clinical trials. Con...

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Veröffentlicht in:	Archives of internal medicine (1960) 2021-11, Vol.181 (11), p.1521-1522
Hauptverfasser:	Naci, Huseyin, Guan, Xiaodong, Woloshin, Steven, Xu, Ziyue, Wagner, Anita K
Format:	Artikel
Sprache:	eng
Schlagworte:	Access to Information Antineoplastic Agents - pharmacology Cancer therapies Clinical outcomes Data Display Descriptive labeling Drug Approval - methods Drug Labeling - methods Drug Labeling - standards FDA approval Humans Letters Neoplasms - drug therapy Neoplasms - mortality Online First Research Design - standards Research Letter Survival Analysis United States United States Food and Drug Administration
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Beschreibung
Zusammenfassung:	Naci et al examine how information on overall survival benefits of novel cancer drug indications is communicated in labeling. Overall survival (OS) - how long patients live after treatment - is arguably the most definitive patient-relevant outcome when evaluating cancer drugs in clinical trials. Consistently communicating the association of cancer drugs with OS in US Food and Drug Administration (FDA)-approved labeling can help inform treatment decisions.
ISSN:	2168-6106 2168-6114
DOI:	10.1001/jamainternmed.2021.3505