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Activity Number:
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325
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305786 |
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Title:
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Understanding the Key Factors in the Design of a Randomized Thorough QT Study
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Author(s):
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Jessie Qing Xia*+ and Alexei A. Dmitrienko and Beasley Charles and S. Stanley Young
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Companies:
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National Institute of Statistical Sciences and Eli Lilly and Company and Eli Lilly and Company and National Institute of Statistical Sciences
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Address:
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19 T.W. Alexander Drive, Research Triangle Park, NC, 27709,
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Keywords:
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cardiac safety ; drug safety ; QT interval prolongation ; QT correction
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Abstract:
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A thorough QT study for monitoring drug cardiac safety requires several key elements to form a good experimental design. In this study, we conducted a comprehensive evaluation of these elements using a mixed effects model. When the number of QT measurements at each time point is greater than 4, the estimation is stabilized. The double delta calculation of treatment difference, which is to subtract the baseline values from the value at the time of interest in each arm and then contrast between the drug and placebo arms, is advantageous to both the simple delta and triple delta calculation. With a proper number of baseline QT measurements, the individual QT correction strategy is comparable with the model based QT correction strategy. For the individual QT correction, the choice of the QT-RR model is not critical.
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