| Evaluating candidate principal surrogate endpoints. | |
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MedLine Citation:
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PMID: 18363776 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Peter B Gilbert; Michael G Hudgens |
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Publication Detail:
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Type: Journal Article; Research Support, N.I.H., Extramural Date: 2008-03-24 |
Journal Detail:
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Title: Biometrics Volume: 64 ISSN: 1541-0420 ISO Abbreviation: Biometrics Publication Date: 2008 Dec |
Date Detail:
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Created Date: 2008-11-26 Completed Date: 2008-12-31 Revised Date: 2013-05-20 |
Medline Journal Info:
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Nlm Unique ID: 0370625 Medline TA: Biometrics Country: United States |
Other Details:
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Languages: eng Pagination: 1146-54 Citation Subset: IM |
Affiliation:
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Department of Biostatistics, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington 98109, USA. pgilbert@scharp.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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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:
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2 R01 AI54165-04/AI/NIAID NIH HHS; 5 R37 AI029168-16/AI/NIAID NIH HHS; R01 AI054165-04/AI/NIAID NIH HHS; R01 AI054165-06/AI/NIAID NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/AIDS Vaccines; 0/Biological Markers |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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