Preceding our 8th Annual Statistical Issues Workshop, the American Statistical Association is co-sponsoring a short course on Adaptive Design. The course will be taught by Dr. Christopher Coffey, University of Iowa.

In recent years, there has been substantial interest in the use of adaptive or novel randomized trial designs. Adaptive clinical trial designs provide the flexibility to make adjustments to aspects of the design of a clinical trial based on data reviewed at interim stages. Although there are a large number of proposed adaptations, all generally share the common characteristic that they allow for some design modifications during an ongoing trial. Unfortunately, the rapid proliferation of research on adaptive designs, and inconsistent use of terminology, has created confusion about the similarities, and more importantly, the differences among the techniques. Furthermore, the implementation of adaptive designs to date does not seem consistent with the increasing attention provided to these designs in the statistical literature. This workshop will attempt to clarify some of the confusion surrounding the use of these methods, as well as provide examples where they have been used in the past.

The workshop will be structured in two parts:
• The first part of the course will provide some clarification on the topic and describe some of the more commonly proposed adaptive designs. It will also focus on some specific barriers that impede the use of adaptive designs in the current environment, and will discuss future work that is needed in order to ensure that investigators can achieve the promised benefits of adaptive designs.
• The second part of the course will provide a more in-depth discussion of the theory and implementation of adaptive designs in real-world settings. The presenter will draw from several recent examples of studies implementing adaptive designs, and will address the strengths and weaknesses of the approaches used. This part of the course will also summarize the results of a couple of recently completed surveys to assess the interest and attitudes of the clinical trials community in general with respect to the use of adaptive designs.