ABSTRACT
Noninferiority of a diagnostic test to the standard is a common issue in
medical research. For instance, we may be interested in determining if a
new diagnostic test is noninferior to the standard reference test because
the new test might be inexpensive to the extent that some small inferior
margin in sensitivity or specificity may be acceptable. Noninferiority trials
are also found to be useful in clinical trials, such as image studies, where
the data are collected in pairs. In such a trial sensitivity and specificity are
often the two coprimary endpoints. It is usually required to demonstrate
that the method is superior to the control in sensitivity and noninferior
in specificity. In this chapter, we study how to design such a trial using
an adaptive approach for adaptive noninferiority trial with paired binary
data, including a trial example and providing the SAS program for the
design simulations.
