Document Detail


Evaluating candidate principal surrogate endpoints.
MedLine Citation:
PMID:  18363776     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Frangakis and Rubin (2002, Biometrics 58, 21-29) proposed a new definition of a surrogate endpoint (a "principal" surrogate) based on causal effects. We introduce an estimand for evaluating a principal surrogate, the causal effect predictiveness (CEP) surface, which quantifies how well causal treatment effects on the biomarker predict causal treatment effects on the clinical endpoint. Although the CEP surface is not identifiable due to missing potential outcomes, it can be identified by incorporating a baseline covariate(s) that predicts the biomarker. Given case-cohort sampling of such a baseline predictor and the biomarker in a large blinded randomized clinical trial, we develop an estimated likelihood method for estimating the CEP surface. This estimation assesses the "surrogate value" of the biomarker for reliably predicting clinical treatment effects for the same or similar setting as the trial. A CEP surface plot provides a way to compare the surrogate value of multiple biomarkers. The approach is illustrated by the problem of assessing an immune response to a vaccine as a surrogate endpoint for infection.
Authors:
Peter B Gilbert; Michael G Hudgens
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural     Date:  2008-03-24
Journal Detail:
Title:  Biometrics     Volume:  64     ISSN:  1541-0420     ISO Abbreviation:  Biometrics     Publication Date:  2008 Dec 
Date Detail:
Created Date:  2008-11-26     Completed Date:  2008-12-31     Revised Date:  2014-09-10    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1146-54     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
AIDS Vaccines
Biological Markers*
Biometry / methods*
Endpoint Determination*
Humans
Immunity
Infection / therapy
Likelihood Functions
Predictive Value of Tests*
Randomized Controlled Trials as Topic
Treatment Outcome*
Grant Support
ID/Acronym/Agency:
2 R01 AI54165-04/AI/NIAID NIH HHS; 5 R37 AI029168-16/AI/NIAID NIH HHS; R01 AI029168/AI/NIAID NIH HHS; R01 AI054165/AI/NIAID NIH HHS; R01 AI054165-04/AI/NIAID NIH HHS; R01 AI054165-06/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/AIDS Vaccines; 0/Biological Markers
Comments/Corrections

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