The US Food and Drug Administration’s use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation-Reference-Cited by-同舟云学术

The US Food and Drug Administration’s use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation

Published:2018-03 Issue:3 Volume:29 Page:527-529
ISSN:0923-7534
Container-title:Annals of Oncology
language:en
Short-container-title:Annals of Oncology

Author:

DeLoughery E.P.,Prasad V.

Funder

Laura and John Arnold Foundation

Publisher

Elsevier BV

Subject

Oncology,Hematology

Link

http://academic.oup.com/annonc/article-pdf/29/3/527/24530966/mdy008.pdf

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4. Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non–small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses;Blumenthal;J Clin Oncol,2015

5. Strength of validation for surrogate end points used in the US Food and Drug Administration's approval of oncology drugs;Kim;Mayo Clinic Proc,2016

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