Abstract #301520

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JSM 2003 Abstract #301520
Activity Number: 247
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301520
Title: Using Surrogate Endpoints to Test Anthrax Vaccine
Author(s): Samantha R. Cook*+ and Donald B. Rubin
Companies: Harvard University and Harvard University
Address: Department of Statistics, Cambridge, MA, 02138-2901,
Keywords: causal inference ; principal stratification ; surrogate outcomes ; instrumental variables
Abstract:

The Centers for Disease Control and Prevention (CDC) are currently conducting a study to test the safety and efficacy of the anthrax vaccine (AVA). The study involves both human and macaque (rhesus monkey) subjects; this presentation focuses on the macaque study. Macaques are given varying doses of vaccine, antibodies and other biomarkers are measured, and the macaques are then "challenged" with anthrax. The goal is to determine which biomarkers predict immunity for anthrax and then use these biomarkers as surrogate outcomes in vaccinated humans. We consider surrogate outcomes in the context of the Rubin causal model. By using principal stratification we can treat the (partially unobserved) vector of biomarkers under different treatments as a covariate and condition on it. This idea generalizes models developed for analyzing data from randomized experiments with noncompliance.


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