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Activity Number:
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14
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 3, 2008 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301095 |
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Title:
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Adaptive Group-Sequential Design and Analysis for Correlated Binary Data on Repeated Venous Accessions
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Author(s):
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John C. Evans*+ and Brian P. Johnson and So Jung Imm
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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100 Boston Scientific Way, Marlboro, MA, 01752-1242,
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Keywords:
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Adaptive group-sequential design ; Sample size re-estimation ; Repeated measures ; Correlated binary data
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Abstract:
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We present adaptive group-sequential designs for correlated binary repeated measures in a venous access study to compare proportions of complications on implantable ports. We estimate the correlation and average frequency of accessions at the interim analysis, and the treatment effect, and then use them to re-estimate the sample size for the final analysis. Whilst allowing for both the interim analysis to be done, and the correlation and frequency of accessions and treatment effect to be estimated, we ensure preservation of the overall significance level. We compare sample sizes and interim and final analyses under the usual assumption of independence, with those obtained when an unknown positive correlation is estimated at the interim analysis.
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