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Activity Number:
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145
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308834 |
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Title:
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New Tests for Assessing Noninferiority and Equivalence from Survival Data
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Author(s):
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Kallappa Koti*+
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Companies:
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Food and Drug Administration
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Address:
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DBV, Silver Spring, MD, 20993,
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Keywords:
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Two-arm trials ; Right-censored data ; Kaplan-Meier estimate ; Generic drugs
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Abstract:
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We propose a new method for assessing non-inferiority of an experimental therapy compared to a standard of care. The ratio µE/µR of true median survival times is the parameter of interest. We think of the ratio mE/mR of the sample medians as a point estimate of the ratio µE/µR. We use the Fieller-Hinkley distribution of the ratio of two normally distributed random variables to derive a level-a test of inferiority null hypothesis, which is stated in terms of the ratio µE/µR and a pre-specified fixed non-inferiority margin. We also explain how to assess equivalence and non-inferiority using bootstrap equivalent confidence intervals on the ratio µE/µR. We discuss sample size determination. The proposed new test does not require the hazard rates to be proportional. We claim that our test procedure is simple and attains adequate power for moderate sample sizes.
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