Blinded Independent Central Review of the Progression-Free Survival Endpoint-Reference-Cited by-同舟云学术

Blinded Independent Central Review of the Progression-Free Survival Endpoint

Published:2010-04-11 Issue:5 Volume:15 Page:492-495
ISSN:1083-7159
Container-title:The Oncologist
language:en
Short-container-title:

Author:

Amit Ohad¹,Bushnell Will¹,Dodd Lori²,Roach Nancy³,Sargent Daniel⁴

Affiliation:

1. a GlaxoSmithKline, Collegeville, Pennsylvania, USA

2. b National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA

3. c Colorectal Cancer Coalition, Alexandria, Virginia, USA

4. d Mayo Clinic, Rochester, Minnesota, USA

Abstract

Presented are the efforts of the Pharmaceutical Research and Manufacturing Association PFS Working Group to address concerns related to blinded independent central review of locally evaluated progression times and the proposed audit methodology to minimize potential biases, along with the U.S. Food and Drug Administration's comments on this work.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1634/theoncologist.2009-0261

Reference5 articles.

1. Proposal for the use of progression-free survival in unblinded randomized trials;Freidlin;J Clin Oncol,2007

2. Operational bias in assessing time to progression (TTP) [abstract 975];Williams;Proc Am Soc Clin Oncol,2002

3. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?;Dodd;J Clin Oncol,2008

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