Document Detail

Surrogate endpoints in clinical trials: definition and operational criteria.
MedLine Citation:
PMID:  2727467     Owner:  NLM     Status:  MEDLINE    
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.
R L Prentice
Related Documents :
10065917 - The analgesic effects of selective serotonin reuptake inhibitors.
7041027 - Report on various clinical studies on high dose methotrexate in europe (non eortc).
22892547 - Manager support for work-family issues and its impact on employee-reported pain in the ...
18380637 - Practical guidelines for economic evaluations alongside equivalence trials.
20938477 - Orthognathic treatment and temporomandibular disorders - part 2.
12025937 - Seasonal variation in effect of spa therapy on chronic pain.
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    
Fred Hutchinson Cancer Research Center, Seattle, WA 98104.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Breast Neoplasms / prevention & control
Clinical Trials as Topic / methods*
Mass Screening / methods
Neoplasms / mortality,  prevention & control
Research Design
Statistics as Topic
Grant Support

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

Previous Document:  Surrogate endpoints in clinical trials: ophthalmologic disorders.
Next Document:  How study design affects outcomes in comparisons of therapy. I: Medical.