An Introduction To Applications Of Adaptive Design

The deployment of adaptive design approaches has been seen at the strategic / operational level of many pharmaceutical and biotech companies as a means to improve risk management, increase the speed and efficiency of their drug development programs, and more efficiently manage their budget and resources. Most importantly these approaches are seen as a mechanism to help identify failures early, while for potentially successful drugs they provide a strategy for bringing them to market earlier, leading to an increased return on investment (ROI).

Furthermore, the adoption of an adaptive design strategy across the product development process brings a number of important benefits; most importantly increased probability of success at various stages of clinical development. We are all too familiar with the worrying industry statistic that more than half of Phase II and phase III studies fail due to lack of efficacy; see Schuhmacher et al. [1]. Adaptive design trials offer the potential to change this industry statistic and dramatically increase the ability of pharmaceutical companies to successfully bring more effective treatments to the market. Companies that adopt a comprehensive adaptive design strategy across their product pipeline will make better development decisions and ultimately bring effective products to the market more quickly.