ABSTRACT
This chapter focuses on some of the practical aspects of conducting adaptive trials, in particular the infrastructure required to operate these studies appropriately and smoothly. Although many of our recommendations and considerations apply to a range of types of adaptive trial, we concern ourselves primarily with those designs that include preplanned adjustments to the randomization procedure or to the number of treatment arms in play. Such designs bring with them unique challenges for those managing clinical trials, some of which require adjustments to processes and procedures, careful planning and consideration, and the implementation of technologies to ensure the study runs smoothly. These we consider as adaptive infrastructure-the elements that those putting in place an adaptive clinical trial should consider to ensure effective implementation and appropriate compliance with regulatory guidance and thinking.
