Statistical controversies in clinical research: An initial evaluation of a surrogate end point using a single randomized clinical trial and the Prentice criteria Journal Article


Author: Heller, G.
Article Title: Statistical controversies in clinical research: An initial evaluation of a surrogate end point using a single randomized clinical trial and the Prentice criteria
Abstract: Surrogate end point research has grown in recent years with the increasing development and usage of biomarkers in clinical research. Surrogacy analysis is derived through randomized clinical trial data and it is carried out at the individual level and at the trial level. A common surrogate analysis at the individual level is the application of the Prentice criteria. An approach for the evaluation of the Prentice criteria is discussed, with a focus on its most difficult component, the determination of whether the treatment effect is captured by the surrogate. An interpretation of this criterion is illustrated using data from a randomized clinical trial in prostate cancer. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Keywords: randomized clinical trial; surrogate end point; equivalence test; prentice criteria
Journal Title: Annals of Oncology
Volume: 26
Issue: 10
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2015-10-01
Start Page: 2012
End Page: 2016
Language: English
DOI: 10.1093/annonc/mdv333
PROVIDER: scopus
PUBMED: 26254442
PMCID: PMC4692987
DOI/URL:
Notes: Export Date: 2 November 2015 -- Source: Scopus
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  1. Glenn Heller
    399 Heller