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Activity Number:
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469
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Type:
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Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306045 |
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Title:
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Simultaneous Test for Superiority and Noninferiority Hypotheses in Active Controled Clinical Trials
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Author(s):
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Joanne Zhang*+ and Yi Tsong
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Companies:
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Center for Drug Evaluation and Research and U.S. Food and Drug Administration
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Address:
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Room 5231, Building 22, 10903 New Hampshire Ave., Silver Spring, 20993,
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Keywords:
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cross-trial comparison ; generalized historical control ; simultaneous test ; non-inferiority ; superiority ; active controlled clinical trials
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Abstract:
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Two-stage switching between testing for superiority (SUP) and non-inferiority (NI) has been an important statistical issue in the design and analysis of the active controlled clinical trials. Tsong and Zhang (2005) have shown that the type I error rates do not change when switching between SUP and NI with the traditional generalized historical control (GHC) approach; however, they may change when switching with the cross-trial comparison (X-trial) approach. They further proposed a simultaneous test for both hypotheses to avoid the problem. Tsong and Zhang (2005) proved the existence of the confidence interval for the simultaneous test. Through a simulation study, it is shown that the type I error rate and power between the simultaneous test and the conventional superiority test are smaller than the difference between the results of t-test and the normal asymptotic test.
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