Blinded independent central review of the progression-free survival endpoint

Oncologist

Volumn 15, Issue 5, 2010, Pages 492-495

  Amit, Ohad ^a   Bushnell, Will ^a   Dodd, Lori ^b   Roach, Nancy ^c   Sargent, Daniel ^d  

^a GLAXOSMITHKLINE   (United States)

^b NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^c C3: Colorectal Cancer Coalition   (United States)

^d MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BLINDED INDEPENDENT CENTRAL REVIEW; CANCER SURVIVAL; CLINICAL RESEARCH; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL AUDIT; METHODOLOGY; PEER REVIEW; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SYSTEMATIC ERROR; TREATMENT OUTCOME;

CLINICAL TRIALS, PHASE III AS TOPIC; DATA COLLECTION; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; HUMANS; MEDICAL AUDIT; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 77952600681     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2009-0261     Document Type: Article

References (5)

1. Freidlin B, Korn EL, Hunsberger S et al. Proposal for the use of progression freesurvivalinunblindedrandomizedtrials.JClinOncol2007;25:2122-2126.
2. Williams G, He K, Chen G et al. Operational bias in assessing time to progression (TTP) [abstract 975]. Proc Am Soc Clin Oncol 2002;20:244a.
3. Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), UpdatedJanuary 2009. Available at http://www.recist.com/recist-in-practice/01.html, accessed September 3, 2009.
4. Dodd LE, Korn EL, Freidlin B et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008;26:3791-3796.
5. U.S. Department of Health and Human Services. FDA Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, May 2007. Available at http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf, accessed September 3, 2009.