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

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307600
Title: Calculating an Exact p-Value for a Noninferiority Test on Matched Pair Data
Author(s): Jennifer E. Hamer-Maansson*+
Companies: AstraZeneca
Address: 1800 Concord Pike, Wilmington, DE, 19810,
Keywords: non-inferiority ; crossover ; McNemar ; matched ; pair

When testing matched pair data with binary responses for equivalence, one can use a McNemar's test to calculate the p-value. When matched pair data was tested for non-inferiority, the McNemar's test needed to be modified. Using the method presented in Sidik's paper (Statistics in Medicine 2003), a SAS program was created to calculate an exact p-value for a non-inferiority test. The program was then applied to two clinical trials with a 2x2 crossover design to compare a test treatment with a reference treatment for non-inferiority in terms select adverse events.

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