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

Cited by 35 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Meta-Analysis of 49 Roche Oncology Trials Comparing Blinded Independent Central Review (BICR) and Local Evaluation to Assess the Value of BICR;The Oncologist;2023-03-11

2. What is the weight of expectation bias in oncology trials?;British Journal of Clinical Pharmacology;2023-02-11

3. Tumor Response, Disease Control, and Progression-Free Survival as Surrogate Endpoints in Trials Evaluating Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: Study- and Patient-Level Analyses;Cancers;2022-12-28

4. Value of central review of RECIST v1.1 outcomes in the AGITG INTEGRATE randomised phase 2 international trial for advanced oesophago-gastric cancer;Journal of Cancer Research and Clinical Oncology;2022-10-31

5. Value of Central Review of RECIST v1.1 Outcomes in the AGITG INTEGRATE randomised phase 2 international trial for advanced oesophago-gastric cancer;2022-08-19