Document Detail

Prentice's approach and the meta-analytic paradigm: a reflection on the role of statistics in the evaluation of surrogate endpoints.
MedLine Citation:
PMID:  15339295     Owner:  NLM     Status:  MEDLINE    
We put a perspective on the strengths and limitations of statistical methods for the evaluation of surrogate endpoints. Whereas using several trials overcomes some of the limitations of a single-trial framework (Prentice, 1989, Statistics in Medicine 8, 431-440), arguably the evaluation of surrogate endpoints can never be done using only statistical evidence but such evidence should be seen as but one component in a decision-making process that involves, among others, a number of clinical and biological considerations. We briefly present a hierarchical framework that incorporates ideas from Prentice's work and is uniformly applicable to different types of surrogate and true clinical outcomes.
Ariel Alonso; Geert Molenberghs; Tomasz Burzykowski; Didier Renard; Helena Geys; Ziv Shkedy; Fabián Tibaldi; José Cortiñas Abrahantes; Marc Buyse
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Biometrics     Volume:  60     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  2004 Sep 
Date Detail:
Created Date:  2004-09-01     Completed Date:  2005-03-01     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  724-8     Citation Subset:  IM    
Center for Statistics, Limburgs Universitair Centrum, Diepenbeek, Belgium.
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MeSH Terms
Biometry / methods*
Clinical Trials as Topic / statistics & numerical data*
Endpoint Determination / statistics & numerical data*
Interferon Type I, Recombinant / therapeutic use
Likelihood Functions
Macular Degeneration / drug therapy,  physiopathology
Meta-Analysis as Topic*
Models, Statistical
Visual Acuity / drug effects
Reg. No./Substance:
0/Interferon Type I, Recombinant
Comment In:
Biometrics. 2007 Sep;63(3):958-62; author reply 962-3   [PMID:  17825025 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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