The need for more efficient trial designs.

The development lifecycle of most clinical products eventually includes the requirement of clinical trials. The objective of the clinical trials usually is the demonstration of the safety and efficacy of the product. The standard methods for sample size determination of these trials have the potential to be extremely inefficient. Adaptive techniques, in certain circumstances, have the potential to result in much more efficient designs. This would then result in the reduction of unnecessary additional exposure of study subjects to experimental products, and help minimize the costs and time to arrive at a statistically appropriate answer to the primary study questions. Copyright 2006 John Wiley & Sons, Ltd.