More clinical studies are using adaptive strategies because of their success in reducing development time and cost. However, their implementation is often suboptimal because of an exclusive focus on statistical (design) issues. Adaptive strategies can have a far more powerful benefit by considering a comprehensive approach. Unlike design adaptations, operational adaptations do not require regulatory approval and thus can be rapidly and flexibly adopted. Since both design and operational adaptations rest on a common technology platform, both types of adaptations should be considered. Used together, design and operational adaptations can reduce development times. This session examines lessons learned from conducting more than 50 adaptive programs.

• Appreciate the breadth of adaptive components possible and how they affect different aspects of study design and conduction
• Understand the common technology platform required for the effective implementation of any adaptive component
• Use adaptive elements to improve decision making on multiple levels,particularly in reducing cycle decision times