Adaptive Seamless Phase II/III Designs—Background, Operational Aspects, and Examples

Abstract

Adaptive seamless designs have been considered as one possible way to shorten the time and patient exposure necessary to discover, develop, and demonstrate the benefits of a new drug. We introduce the concept of adaptive designs and describe the current statistical methodologies that relate to adaptive seamless designs. We also describe the decision process involved with seamless designs and present some illustrative examples.