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Abstract Details
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Activity Number:
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68
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300576 |
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Title:
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Statistical Evaluation of Diurnal Effects in Parallel-Group Thorough QT/QTc Studies
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Author(s):
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Guowen "Gordon" Sun*+ and Hui Quan and Robert Kringle
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Companies:
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Celgene Corporation and sanofi-aventis and sanofi-aventis
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Address:
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3 Ash CT, Clinton, NJ, 08809,
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Keywords:
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thorough QT/QTc studies ;
diurnal effects ;
parallel studies ;
hypothesis test
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Abstract:
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In the analysis of parallel-group thorough QT/QTc studies, time-matched baseline is often used per ICH E14 guidance. However, the justification is primarily based on assumption that subjects have the same diurnal patterns on different days. Clearly, the magnitude of within-subject variability for time-matched change from baseline has substantial impact on the power of the primary hypothesis test for the analyses of thorough QT/QTc studies. In this paper, we developed statistics to simultaneously evaluate the consistency of subjects' diurnal patterns as well as the within-subject variation and applied these statistics to historical thorough QT/QTc studies. We conclude that the power using day-averaged baseline is less sensitive to within-subject variability as compared to the time-matched baseline and is generally preferred in the analysis of parallel-group thorough QT/QTc studies.
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