JSM 2005 - Toronto

Abstract #302474

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 243
Type: Invited
Date/Time: Tuesday, August 9, 2005 : 10:30 AM to 12:20 PM
Sponsor: ENAR
Abstract - #302474
Title: Statistical Issues Arising in the Women's Health Initiative
Author(s): Ross Prentice*+
Companies: Fred Hutchinson Cancer Research Center
Address: 1100 Fairview Ave N, POB 19024, M3-A410, Seattle, WA, 98109-1024,
Keywords: genome-wide scan ; measurement error ; hazard ratio ; nutritional epidemiology ; observational study ; randomized controlled trial
Abstract:

A brief overview of the design of the Women's Health Initiative (WHI) Clinical Trial and Observational Study is provided in this paper, along with a summary of early results from the postmenopausal hormone therapy clinical trial components. Since its inception in 1992, the WHI has been faced with a number of statistical issues where further methodology developments are needed. These include measurement error modeling and analysis procedures for dietary assessment; clinical trial monitoring methods when treatments may affect multiple clinical outcomes, either beneficially or adversely; study design and analysis procedures for high-dimensional genomic and proteomic data; and failure time data analysis procedures when treatment group hazard ratios are time-dependent. This final topic seems important in resolving the discrepancy between WHI Clinical Trial results and observational studies of postmenopausal hormone therapy and cardiovascular disease.


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Revised March 2005