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.

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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