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Activity Number:
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335
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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ENAR
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| Abstract - #308250 |
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Title:
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Proportion of Treatment Effect Explained by a Continuous Surrogate Marker
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Author(s):
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Jie Huang*+ and Bin Huang
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Companies:
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Novartis Pharmaceuticals and Cincinnati Children's Hospital Medical Center
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Address:
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170 Park Avenue, Florham Park, NJ, 07936-1080,
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Keywords:
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Surrogate ; Prentice Criteria ; Freedman's PTE ; Wang and Taylor's F(F`) ; Probit Regression ; Clinical Trial
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Abstract:
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Using surrogate endpoint in clinical trial is desirable for drug development because the trial will be cost-effective. Validating surrogate endpoint for clinical endpoint is critical to warrant such use. Since Prentice's definition (1989), different proposals were made to define proportion of treatment effect explained (PTE) by a surrogate. This paper extended Wang and Taylor's (2002) work for the case of continuous surrogate marker and binary outcome/treatment, which is one of the most common settings in clinical trial. We provided an easy and accurate solution to measure the proportion of treatment effect explained by a continuous surrogate endpoint. Further, we provided a simple graphical presentation of the surrogate effect. Both simulation results and actual trial example were produced to compare this alternative measure with Freedman's (1992) PTE measure.
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