Document Detail

A perspective on surrogate endpoints in controlled clinical trials.
MedLine Citation:
PMID:  15198486     Owner:  NLM     Status:  MEDLINE    
The last couple of decades have seen a large amount of activity in the area of surrogate marker and surrogate endpoint validation, both from a clinical and a statistical perspective. Prentice made a pivotal contribution in the context of a single trial. Subsequently, the framework he proposed has been discussed, criticized, and extended. An important class of extensions considers several rather than a single trial. Recently, a lot of work has been done in this so-called hierarchical or meta-analytic framework. In this paper, we review both the single trial and the hierarchical framework. A number of applications, scattered throughout the literature, are brought together. We outline the statistical issues involved in trying to validate surrogate endpoints. Clearly statistical evidence should only be seen as a component in a decision making process that also involves a number of clinical and biological considerations.
Geert Molenberghs; Tomasz Burzykowski; Ariel Alonso; Marc Buyse
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Statistical methods in medical research     Volume:  13     ISSN:  0962-2802     ISO Abbreviation:  Stat Methods Med Res     Publication Date:  2004 Jun 
Date Detail:
Created Date:  2004-06-16     Completed Date:  2004-09-21     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9212457     Medline TA:  Stat Methods Med Res     Country:  England    
Other Details:
Languages:  eng     Pagination:  177-206     Citation Subset:  IM    
Center for Statistics, Limburgs Universitair Centrum, Diepenbeek, Belgium.
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MeSH Terms
Antineoplastic Agents, Hormonal / therapeutic use
Biological Markers*
Controlled Clinical Trials as Topic / methods*
Imidazoles / therapeutic use
Models, Statistical*
Predictive Value of Tests
Prostatic Neoplasms / drug therapy
Treatment Outcome
Reg. No./Substance:
0/Antineoplastic Agents, Hormonal; 0/Biological Markers; 0/Imidazoles; 115575-11-6/liarozole

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