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Abstract Details
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Activity Number:
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35
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Type:
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Contributed
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Date/Time:
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Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304892 |
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Title:
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Designs for Randomized Phase II Clinical Trials
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Author(s):
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Myron Chang*+ and Wei Hou and Sin-Ho Jung and Yang Li
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Companies:
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University of Florida and University of Florida and Duke University and University of Florida
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Address:
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1465 SW 88th St, Gainesville, FL, 32607, United States
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Keywords:
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single-stage design ;
two-stage design ;
type I error rate ;
power ;
threshold ;
average sample size
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Abstract:
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The primary objective of typical randomized phase II anti-cancer clinical trials is to evaluate experimental treatments that potentially will increase response rate over a historical baseline and select one to consider for further study. We propose single- and two-stage designs for randomized phase II clinical trials, precisely defining various type I error rates and powers in order to achieve this objective. We develop a program to compute these error rates and powers exactly, and we provide many design examples to satisfy prefixed requirements on error rates and powers. Finally, we apply our method to a randomized phase II trial in patients with relapsed non-Hodgkin's disease.
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Authors who are presenting talks have a * after their name.
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