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Activity Number:
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438
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Type:
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Contributed
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Date/Time:
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Thursday, August 12, 2004 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301089 |
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Title:
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An Application of Repeated Measures Analysis in a Two-period, Longitudinal Cross-over Study
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Author(s):
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Xiaojing Wang*+ and Guanghan F. Liu and Duane Snavely and Al Getson
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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10 Sentry Pkwy., BL3-2, Blue Bell, PA, 19422,
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Keywords:
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crossover study ; longitudinal method ; repeated measures ; analysis of variance
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Abstract:
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In the early stages of clinical development, cross-over designs are often used to obtain adequate study power with a smaller number of patients. To take full advantage of the crossover design, it requires an assumption of no carry-over effect. Without carry-over effect, the treatment comparison can be made within subject.The study gains more power because within subject variance is usually smaller than between subject variance. When the primary efficacy variable is measured several times within a period, a longitudinal method may be considered for the analysis of the cross-over study data. This method will have some advantage over a conventional statistical analysis method since all observed data can be used in the analysis regardless of whether a patient completes or discontinues prematurely from the study. Statistical tests for sequence and period effects as well as for the treatment comparison of the primary endpoint will be discussed. Simulations will be used to illustrate the method and will be compared with the conventional analysis of variance model.
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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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