I，dlike to talk about practical experience in applying adaptive clinical trials in the United States, and give you two examples of trials that have actually been completed or are currently running. All completely pre-specified but they are of the type that the FDA (Food and Drug Administration) calls "less well understood" because they involved adaptations based on unblinded interim analyses. Our group has lots of experience meeting with the FDA and talking about these kinds of unblinded interim analyses and adaptations. And I can tell you that the FDA is rapidly becoming more comfortable and more understanding of those approaches.
展开▼
