Document Detail

Surrogate endpoints in clinical trials: cardiovascular diseases.
MedLine Citation:
PMID:  2727465     Owner:  NLM     Status:  MEDLINE    
A surrogate endpoint in a cardiovascular clinical trial is defined as endpoint measured in lieu of some other so-called 'true' endpoint. A surrogate is especially useful if it is easily measured and highly correlated with the true endpoint. Often the 'true' endpoint is one with clinical importance to the patient, for example, mortality or a major clinical outcome, while a surrogate is one biologically closer to the process of disease, for example, ejection fraction. Use of the surrogate can often lead to dramatic reductions in sample size and much shorter studies than use of the true endpoint. We discuss several problems common in trials with surrogate endpoints. Most important is the effect of missing data, especially in the face of informative censoring. Possible solutions are the assignment of scores or formal penalties to missing data.
J Wittes; E Lakatos; J Probstfield
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Publication Detail:
Type:  Journal Article    
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:  415-25     Citation Subset:  IM    
Biostatistics Research Branch, National Heart, Lung, and Blood Institute, Bethesda, MD 20892.
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MeSH Terms
Cardiovascular Diseases / drug therapy*,  mortality
Clinical Trials as Topic / methods*
Research Design
Statistics as Topic

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