FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019

FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019

This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.

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Bibliographische Detailangaben
Veröffentlicht in:JAMA internal medicine 2020-06, Vol.180 (6), p.912-914
Hauptverfasser: Chen, Emerson Y, Haslam, Alyson, Prasad, Vinay
Format: Artikel
Sprache:eng
Schlagworte:
Antineoplastic Agents - pharmacokinetics
Biomarkers, Tumor - metabolism
Drug Approval - legislation & jurisprudence
Humans
Letters
Neoplasms - drug therapy
Neoplasms - metabolism
Online First
Research Letter
Retrospective Studies
United States
United States Food and Drug Administration
Online-Zugang:Volltext
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Beschreibung
Zusammenfassung:This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.
ISSN:2168-6106
2168-6114
DOI:10.1001/jamainternmed.2020.1097