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Abstract Details
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Activity Number:
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580
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300972 |
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Title:
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One-Sample Proportion Testing Procedures for Hypothesis of Inequality
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Author(s):
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Wayne Zhong and Bob Zhong*+
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Companies:
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Octagon Research Solutions, Inc. and Johnson & Johnson Pharmaceutical R&D, LLC
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Address:
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200 Great Valley Parkway, Malvern, PA, 19355,
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Keywords:
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Single arm ;
Phase 2 clinical trial ;
Hypothesis of inequality ;
exact binomial distribution ;
minimized two-stage design
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Abstract:
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The primary objective of a phase II single arm clinical trial is to determine whether a new treatment is of sufficient activity for a disease to warrant further development. This paper presents one-stage and two-stage designs for testing the response rate of a test treatment against the response rate of an existing treatment. The null and alternative hypotheses are that the response rate of the test treatment are equal and unequal to that of the existing treatment, respectively. The testing procedures are calculated with exact binomial distribution. Two-stage designs presented minimize total sample size and satisfy type I and II error constraints, with flexibility in the first stage sample size.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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