ABSTRACT

One challenge in the development of new and novel medicines is the length of time needed and cost associated with their development as well as the amount of information necessary to demonstrate the benefit of novel medicines. A reasonable goal would include reducing the time needed to collect this information while also increasing the efficiency of the design and analysis. For this reason, there has been much effort in trying to develop clinical trial designs that can improve on both of these aspects. In addition to other clinical trial designs discussed in this book, one possibility is to merge what typically would be separate clinical trials into a single trial. Under proper circumstances, this can reduce the amount of time necessary to complete the overall development process, as well as use the data collected from the trials more efficiently.