Simultaneous testing of noninferiority and superiority increases the false discovery rate.
It is well recognized that multiplicity adjustment is not necessary in simultaneous testing for noninferiority and superiority. However, Ng (2003) 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. This leads to an increase in the false discovery rate for superiority.
Ng
Tie-Hua
TH
US Food and Drug Administration, Rockville, MD 20852-1448, USA. tiehua.ng@fda.hhs.gov
D001499:Bayes Theorem; D016001:Confidence Intervals; D018849:Controlled Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D015233:Models, Statistical; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data*