Abstract Details
Activity Number:
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610
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Type:
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Contributed
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Date/Time:
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Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
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Sponsor:
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Biometrics Section
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Abstract #315953
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View Presentation
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Title:
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Single-Arm Phase II Trial Design Under Parametric Cure Models
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Author(s):
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Jian Rong Wu*
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Companies:
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St. Jude Children's Research Hospital
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Keywords:
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Clinical trial design ;
Cure model ;
Time-to-evnet ;
Sample size ;
Single-arm phase II trial
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Abstract:
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The current practice of designing single-arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single-arm phase II trials under the parametric cure model. In this article, a test statistic is proposed, and a sample size formula is derived for designing single-arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios.
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Authors who are presenting talks have a * after their name.
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