| A perspective on surrogate endpoints in controlled clinical trials. | |
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MedLine Citation:
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PMID: 15198486 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Geert Molenberghs; Tomasz Burzykowski; Ariel Alonso; Marc Buyse |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Statistical methods in medical research Volume: 13 ISSN: 0962-2802 ISO Abbreviation: Stat Methods Med Res Publication Date: 2004 Jun |
Date Detail:
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Created Date: 2004-06-16 Completed Date: 2004-09-21 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9212457 Medline TA: Stat Methods Med Res Country: England |
Other Details:
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Languages: eng Pagination: 177-206 Citation Subset: IM |
Affiliation:
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Center for Statistics, Limburgs Universitair Centrum, Diepenbeek, Belgium. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Antineoplastic Agents, Hormonal
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therapeutic use Biological Markers* Controlled Clinical Trials as Topic / methods* Humans Imidazoles / therapeutic use Male Models, Statistical* Predictive Value of Tests Prostatic Neoplasms / drug therapy Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents, Hormonal; 0/Biological Markers; 0/Imidazoles; 115575-11-6/liarozole |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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