All Times EDT
Keywords: Combination Therapy, futility analysis, adaptive factorial design
Adequate and well-controlled clinical studies are required for applications to market a new drug or biologic. The design of the pivotal clinical studies may vary substantially depending on the investigational drug product, the specific indication for labeling claim, and existing study results. For combination regimens, the drug development strategy should also be able to demonstrate the individual contributions of each component, which will be especially difficult for novel drug combinations. This presentation will discuss the potential study designs for combination regimen under different scenarios. In addition, focus will be given to Phase III confirmatory factorial designs where arm may be dropped for futility. The sample size needed for the treatment arm that may drop for futility will be discussed.