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Activity Number:
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286
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Type:
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Contributed
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Date/Time:
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Tuesday, August 8, 2006 : 10:30 AM to 12:20 PM
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Sponsor:
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Biometrics Section
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| Abstract - #306182 |
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Title:
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Designs for Phase I Clinical Trials with Multiple Courses of Subjects at Different Doses
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Author(s):
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Shenghua Fan*+ and You-Gan Wang
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Companies:
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California State University, East Bay and CSIRO Mathematical and Information Sciences
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Address:
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Department of Statistics, Hayward, CA, 94542,
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Keywords:
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phase I trials ; multiple courses ; isotonic estimates
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Abstract:
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Existing phase I designs assign each subject to one dose level that depends on responses from previous subjects. Yet some of the subjects with neither toxicity nor efficacy responses might be treated at higher dose levels. In addition, for some trials, it might be possible to obtain multiple responses (repeated measures) from a subject at different dose levels. A non-parametric estimation method for such studies will be presented in this talk. We also explore how designs of multiple courses of subjects may be implemented to improve design efficiency. The gain of efficiency from ``single dose per subject'' to ``multiple doses per subject'' are evaluated for several scenarios and for different drop-out rates. Our numerical study show that using ``multiple doses per subject'' and the new estimation method increases the efficiency substantially.
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