This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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632
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Type:
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Contributed
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Date/Time:
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Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Nonparametric Statistics
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Abstract - #306654 |
Title:
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Exact Sample Size Calculations for Noninferiority Trials with Binomial Endpoints
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Author(s):
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Cyrus R. Mehta and Lingyun Liu*+ and Pralay Senchaudhuri
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Companies:
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Cytel Inc.
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Address:
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675 Massachusetts Ave, Cambridge, MA, 02139,
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Keywords:
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Exact test ;
Non-inferiority trial ;
Binomial endpoint
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Abstract:
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Tests of non-inferiority for clinical trials where efficacy is measured by differences and ratios of binomial probabilities typically rely on the asymptotic nomality of the score test (Farrington-Manning, 1990, Miettinen and Nurminen, 1985). It has been shown by Chan (1998) that this test does not preserve the type-1 error when the binomial response rate of the control arm is close to zero or one. Exact tests are available for this setting (StatXact-8, 2008). However, the computational intensity of the calculations inhibits the use of corresponding exact sample size calculations at the design stage. We shall show that the Berger-Boos device (1994) can reduce the computational time and improve the stability of the results without compromising the type-1 error.
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