Document Detail

Surrogate end points in secondary analyses of cardiovascular trials.
MedLine Citation:
PMID:  22226002     Owner:  NLM     Status:  MEDLINE    
A surrogate end point is one that is used as a substitute for a clinical end point of more direct interest, usually for reasons of practicality, and that is expected to predict clinical benefit. Surrogate end points play a critical role in the advancement of all medical research, and cardiovascular (CV) research in particular. However, the relationship between a surrogate end point and its clinical end point is usually complex, and there are many examples where results based on surrogates have proved to be misleading. Secondary analyses of existing clinical trial data are likely to involve surrogate end points, if only because clinical end points will have been extensively studied as part of the primary analysis of a trial large enough to collect useful clinical end point data. Validation of a surrogate end point is a laudable goal for a secondary analysis of a large clinical end point trial (or meta-analysis of multiple smaller trials), and the result may be an important new tool for further study of a class of compounds in a particular disease context. Secondary analyses using surrogate end points may also provide new insight into disease or treatment mechanism, but as with any surrogate end point analysis, the results can mislead, and the existing literature is heavy on application and light on methodology. Surrogate end points often substitute efficiency for clarity, and while many interesting and potentially informative secondary analyses of CV trials will involve surrogates, results are likely to be ambiguous and should be interpreted with care.
Kevin A Buhr
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Progress in cardiovascular diseases     Volume:  54     ISSN:  1873-1740     ISO Abbreviation:  Prog Cardiovasc Dis     Publication Date:    2012 Jan-Feb
Date Detail:
Created Date:  2012-01-09     Completed Date:  2012-02-23     Revised Date:  2013-05-02    
Medline Journal Info:
Nlm Unique ID:  0376442     Medline TA:  Prog Cardiovasc Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  343-50     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
Statistical Data Analysis Center, Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI 53726-2397, USA.
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MeSH Terms
Biological Markers*
Cardiovascular Diseases / therapy*
Clinical Trials as Topic / standards*
Research Design
Statistics as Topic / standards*
Validation Studies as Topic
Reg. No./Substance:
0/Biological Markers

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