Getting the most from adaptive design: Pruning the Thorns
*Marc Walton, FDA CDER 

Keywords: adaptive design, efficiency

Adaptive design clinical trials are recognized as more complex to plan and to conduct than simple fixed designs, but are widely thought to have the potential to significantly improve the efficiency and informativeness of drug development programs. This talk will identify a number of the issues that create difficulties in applying adaptive design to clinical trials in a drug development program, discuss why each is an important issue to be addressed, and some of the trade-offs that can be considered in doing so. In the final measure there are no universal solutions to gaining the full perceived potential from adaptive designs, and each drug development program will need to consider the specific features of each program.