Adaptive trial designs

Abstract

Adaptive designs (AD) have received a great deal of attention in recent years because of the potential they offer to improve the efficiency of clinical drug development. In an increasingly challenging environment, characterized by escalating costs and decreasing likelihood of regulatory approval, sponsors and regulators alike have a keen interest in strategies to modernize drug development - the use of AD is a key one among them. This chapter presents an overview of AD and their use in clinical drug development. It starts with some background and definitions, followed by sections on AD in the Learn and Confirm phases of clinical development. In later sections, the importance of trial simulations in the context of AD is discussed, followed by thoughts on the future of AD. © American Association of Pharmaceutical Scientists 2011.