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Activity Number: 469
Type: Contributed
Date/Time: Wednesday, August 9, 2006 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307148
Title: Simultaneous Testing of Noninferiority and Superiority Increases the False Discovery Rate
Author(s): Tie-Hua Ng*+
Companies: U.S. Food and Drug Administration
Address: 1401 Rockville Pike, Rockville, MD, 20852,
Keywords: active control ; noninferiority ; false discovery rate ; simultaneous testing ; multiplicity adjustment
Abstract:

It is well recognized that multiplicity adjustment is not necessary in simultaneous testing for noninferiority and superiority. However, Ng (2003; Journal of Biopharmaceutical Statistics, 13, 629-662) argued that there will be more experimental treatments that are expected to have the same effect as the active control tested for superiority in simultaneous testing than would occur if only one null hypothesis is tested, thereby increasing erroneous claims of superiority. The proportion of erroneous claims of superiority is analogous to false discovery rate. Therefore, simultaneous testing of noninferiority and superiority increases the false discovery rate of claiming superiority.

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Revised April, 2006