Activity Number:
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108
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Type:
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Contributed
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Date/Time:
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Monday, August 12, 2002 : 10:30 AM to 12:20 PM
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Sponsor:
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ENAR
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Abstract - #301927 |
Title:
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Testing for Treatment Effect in Clinical Trials with Multidimensional Longitudinal Data
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Author(s):
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Mohamed Alosh*+ and Kathleen Fritsch
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Affiliation(s):
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Food and Drug Administration and Food and Drug Administration
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Address:
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9201 Corporate Blvd, HFD-725, Rockville, MD, 20850, USA
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Keywords:
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Clinical Trials ; Longitudinal Data ; Multidimensional Data ; Serial Correlation ; Cross Correlation
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Abstract:
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In the clinical trials setting, efficacy assessment frequently is carried out on several endpoints each measured repeatedly over time. Examples of such multivariate repeated measurements are those related to quality of life and skin photodamage assessments. The choice of a single or limited number of primary endpoints for efficacy evaluation, and whether one considers the final measurement or change over time, requires clinical judgment. However, one of the study objectives might still be evaluation of the overall treatment effect based on a set of the endpoints over the course of the trial. To test for such a treatment effect we propose an extension of the O'Brien procedure for testing multiple endpoints to take into account the repeated measurements over time. We consider a simulation study to investigate the validity of the proposed approach. Also, an application of the proposed method to clinical trial data is presented.
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