Document Detail


Surrogate endpoints in clinical trials: definition and operational criteria.
MedLine Citation:
PMID:  2727467     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
I discuss the idea of using surrogate endpoints in the context of clinical trials to compare two or more treatments or interventions in respect to some 'true' endpoint, typically a disease occurrence. In order that treatment comparison based on a surrogate response variable have a meaningful implication for the corresponding true endpoint treatment comparison, a rather restrictive criterion is proposed for use of the adjective 'surrogate'. Specifically, I propose that a surrogate for a true endpoint yield a valid test of the null hypothesis of no association between treatment and the true response. This criterion essentially requires the surrogate variable to 'capture' any relationship between the treatment and the true endpoint, a notion that can be operationalized by requiring the true endpoint rate at any follow-up time to be independent of treatment, given the preceding history of the surrogate variable. I then discuss this operational criterion in the examples of the accompanying papers and in the setting of trials aimed at the primary and secondary prevention of cancer.
Authors:
R L Prentice
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Statistics in medicine     Volume:  8     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1989 Apr 
Date Detail:
Created Date:  1989-06-29     Completed Date:  1989-06-29     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  431-40     Citation Subset:  IM    
Affiliation:
Fred Hutchinson Cancer Research Center, Seattle, WA 98104.
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MeSH Terms
Descriptor/Qualifier:
Breast Neoplasms / prevention & control
Clinical Trials as Topic / methods*
Female
Humans
Mass Screening / methods
Neoplasms / mortality,  prevention & control
Research Design
Statistics as Topic
Grant Support
ID/Acronym/Agency:
GM-24472/GM/NIGMS NIH HHS

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


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