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Abstract Details

Activity Number: 660
Type: Contributed
Date/Time: Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306330
Title: Prentice Criteria for the Validation of Surrogate Endpoints: An Alternative Formulation
Author(s): Sanatan Saraf*+ and Thomas Mathew and Anindya Roy
Companies: University of Maryland Baltimore County and University of Maryland Baltimore County and University of Maryland Baltimore County
Address: Dept of Mathematics and Statistics, Baltimore, MD, 21250, United States
Keywords: Surrogate Endpoints ; Small sample asymptotics ; Prentice Criteria ; Bootstrap

Statistical validation of a surrogate endpoint has been a topic of active research, motivated by the Prentice criteria, which consist of a set of four criteria. In particular, the fourth criterion implies that the entire effect of the treatment on the true end point is captured by the surrogate end point. For testing the fourth criterion under an appropriate model, we consider an alternative formulation in which we conclude the validity of the fourth criterion based on the rejection of an appropriate hypothesis. Ideas from equivalence testing are used to develop appropriate test procedures, and the performance of the resulting tests are numerically evaluated. Practical recommendations will be made based on the numerical results.

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