ABSTRACT

One of the advantages of adaptive study designs is that they can yield a much richer set of data than non-adaptive designs. Because of this, they are particularly suited for dose-nding studies, and several techniques have been developed for this purpose. A richer set of data is helpful for dose nding because, unlike efcacy endpoints in a conrmatory or hypothesis testing trial where there is a binary answer as to whether the drug works, there is almost never one right dose. With adaptive trial designs, more data can be collected where they will provide the most value, as can be seen in Figure 8.1.