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Abstract Details
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Activity Number:
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34
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Type:
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Contributed
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Date/Time:
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Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301140 |
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Title:
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Joint Modeling of Treatment Effect on Time-to-Event Endpoint and Safety Covariates in Analysis of Controlled Clinical Trial Data
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Author(s):
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Kao-Tai Tsai*+ and Peace Karl
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Companies:
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Georgia Southern University and Georgia Southern University
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Address:
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, , ,
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Keywords:
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Joint Modeling ;
Time-to-Event Data ;
Longitudinal Repeated Measures ;
Control Clinical Trials
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Abstract:
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It is common practice in clinical trials to analyze efficacy and safety data separately to estimate the benefit and risk aspects of a particular treatment regimen. However, given that these data are generated from the same study subjects and therefore are likely correlated, one may miss the complete picture of the treatment effect by separate analyses of efficacy and safety data. Therefore, it is desirable to jointly analyze these data to obtain a more complete profile of the treatment regimen.
A substantial number of statistical methodologies have been proposed in the last decade to model time-to-event data and longitudinal repeated measures jointly. These methods provide better insight to understand the treatment effect in time-to-event data by incorporating the information contained in the longitudinal repeated measures.
In this article, we utilize the joint model method to anal
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