Keywords: Complex Innovative Designs; Simulations; Design Operating Characteristics; PDUFA VI; 21st Century Cures Act
Both the 21st Century Cures Act and the PUDUFA VI legislations emphasize on complex innovative designs, which mean that there are multiple adaptations in a trial; and/orthat it requires simulations to understand trial design operating characteristics. In this presentation, a few examples of utilizing innovative designs (such as a basket design by investigating one drug in multiple indications, and using historical control information to reduce the size of the placebo arm) will be provided to demonstrate how they can improve efficiency in clinical program/study designs in support of product strategies. The role of simulation and challenges and opportunities in considering complex innovative designs also will be discussed.