This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 632
Type: Contributed
Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
Sponsor: Section on Nonparametric Statistics
Abstract - #306654
Title: Exact Sample Size Calculations for Noninferiority Trials with Binomial Endpoints
Author(s): Cyrus R. Mehta and Lingyun Liu*+ and Pralay Senchaudhuri
Companies: Cytel Inc.
Address: 675 Massachusetts Ave, Cambridge, MA, 02139,
Keywords: Exact test ; Non-inferiority trial ; Binomial endpoint
Abstract:

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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