Abstract #301471

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JSM 2003 Abstract #301471
Activity Number: 332
Type: Contributed
Date/Time: Wednesday, August 6, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301471
Title: Analyzing Quality-of-Life Assessment with Missing Data in Clinical Trials
Author(s): Xiaoping Sylvia Hu*+ and Qiuhu Shi
Companies: Roche Labs, Inc. and NY Medical College School of Public Health
Address: 2700 Henry Hudson Pkwy. East, Bronx, NY, 10463,
Keywords: quality of life ; area under the curve ; missing data ; missing mechanism
Abstract:

The quality-of-life assessment is often seen as an important endpoint in clinical trials. The quality-of-life data are usually longitudinal. Summary statistics, such as area under the curve or slope, reduce the dimensionality of the repeated measures data and can thereby simplify the comparison in longitudinal quality of life data. However, missing data adds the complexity to the analysis of the summary statistics. Two analysis methods of analyzing quality of life data with missing data are studied. One method stratifies the summary statistic, another method uses mixed model. Two analyses methods are studied with respect to the test size and the power under different missing data mechanism. Both methods are applied to a quality of life dataset in a clinical trail.

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