JSM 2004 - Toronto

Abstract #301945

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Activity Number: 405
Type: Contributed
Date/Time: Thursday, August 12, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301945
Title: Statistical Validation of Surrgoate Endpoints in HCV Clinical Studies
Author(s): James Jiao*+ and Xiaoping S. Hu and Guoqin Su
Companies: Roche Laboratories, Inc. and Roche Laboratories, Inc. and Novartis
Address: 340 Kingsland Rd., Nutley, NJ, 07110,
Keywords: clinical trial ; HCV ; surrogate endpoint
Abstract:

A statistical definition of surrogate endpoints as well as validation criteria was first presented by Prentice. Freedman et al. supplemented these criteria with the so-called proportion explained (PE). Buyse and Molenberghs proposed a new definition of surrogacy in terms of relative effect (RE) and adjusted association. In clinical studies on HCV disease, there are several potential surrogate endpoints whose surrogacy has not been thoroughly studied yet. The surrogacy of these endpoints will be studied based on (1) proportion explained (PE), and (2) the relative effect (RE) and the treatment-adjusted association between the surrogate endpoint and the true endpoint. The adjusted associations are examined both on individual patient-level and the trial level. Different strategies for the jointly statistical modeling with mixed binary-continuous endpoints are also presented.

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