ABSTRACT
An adaptive seamless phase-II/III design is one of the most attractive adaptive
designs. A seamless adaptive design is a combination of traditional phase-II
and phase-III trials. In seamless design, there is usually a so-called learning
phase that serves the same purpose as a traditional phase-II trial, followed by
a confirmatory phase that serves the same objectives as a traditional phase-
III trial (Figure 7.1). Compared to traditional designs, a seamless design can
reduce sample-size and time-to-market for a positive drug candidate.
