JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 505
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305438
Title: A Meta-Analytic Model for Alzheimer's Disease Incorporating Both Summary-Level and Patient-Level Data
Author(s): James A. Rogers*+ and Bill Gillespie and Kaori Ito and Marc Gastonguay
Companies: Metrum and Metrum and Pfizer Inc. and Metrum
Address: 2 Tunxis Road, Suite 112, Tariffville, CT, 06081,
Keywords: meta-analysis ; longitudinal ; variance components ; Alzheimer's Disease ; Bayesian
Abstract:

The cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) is one of the conventional co-primary endpoints in clinical trials of Alzheimer's Disease (AD). The ability to realistically simulate longitudinal patient-level data for this endpoint is therefore helpful in designing AD clinical trials, in interpreting the results of those trials, and as a means of assessing the plausibility of various hypotheses about the disease. We present a novel approach to the simultaneous modeling of patient-level data (from proprietary sources) with summary data (from published sources), using Bayesian methodology. The incorporation of patient-level data in our meta-analyses enables the estimation of variance components that are relevant to trial design and sample size computations.


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