The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
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 - #302481 |
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Title:
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Optimal Sample Size Allocation in a TQT Study
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Author(s):
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Joanne Zhang*+
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Companies:
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U.S. Food and Drug Administration/CDER
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Address:
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WO21 RM4668 HFD-705, Silver Spring, MD, 20993,
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Keywords:
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Sample size allocation ;
equal sample size ;
efficient allocation
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Abstract:
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It is important to calculate the proper sample size for a Thorough QTc (TQT) study to ensure adequate study power but without wasting unnecessary subjects. In current practice, in order to rule out clinically relevant QT liability of study drug, at least two tasks need to be performed: (a) demonstrating that the largest 90% 2-sided upper confidence bound for the baseline adjusted mean differences between study drug and placebo is less than 10 ms; and (b) demonstrating that assay sensitivity of the study can be established. Traditionally, the sample size is determined by the primary task (a), and then that sample size will be equally assigned into each treatment arm. This practice might not be the most efficient way. In this presentation, an optimal sample size allocation scheme is discussed.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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