LAUSR

present an insightful comparison of 2 clinical trial designs: (1) the actual study design that was implemented in the Stroke Hyperglycemia Insulin Network Effort (SHINE) trial 2 and (2) an alternative nonimplemented design. This comparison was planned before the SHINE study started enrolling patients. Each design can be described as a sequence of decisions after preplanned interim analyses and a plan for final analyses and reporting. The statistical design specifies how the study adapts to the interim data, including actions such early stopping and variations of the randomization probabilities. Broglio and coauthors 1 describe what would have happened if the study team had followed the nonimplemented design. They provide the sequence of decisions that would have been made by using the data that were available for interim analyses during the SHINE clinical trial. Their study precisely mimics the interim decisions that would have been made.