Adaptive and novel study designs
Many aspects of the investigational product, the disease or the study population may have been unknown when the study was planned. In retrospect, when the study is completed, we have gained knowledge, which would have been valuable to know already during the study design phase. Adaptive design permits some of the knowledge gained during the study to be used for improving the design.
The plans and rules for changes (adaptations) need to be well documented in the protocol and statistical analysis plan. The extra time we put into planning, tends to pay off, either by lowering the total cost of the study, or by avoiding costly mistakes. It's time to adapt!