This tutorial will cover an introduction to adaptive designs. The choice of design, adaptive or fixed, depends on many factors (such as uncertainty of compound attributes) and needs to be considered within the context of the entire clinical plan. Expected audiences are both statisticians and non-statisticians who are involved in study planning and execution.
Bayesian and Frequentist methodologies which can be used to perform adaptations in a trial will be described and how they can be used in adaptive designs will be illustrated. Trial simulations are useful and often necessary to understand the operating characteristics of a design. Real examples of simulations will be provided.
Case studies of several types of adaptive designs will be provided including sample size re-estimation, adaptive treatment allocation, group sequential designs, and seamless designs. Regulatory as well as implementation challenges of adaptive designs will be
discussed. Brief summaries in Japanese will be provided between parts.