Response Adaptive Randomization in Clinical Trials for Predictive Marker Validation
*Thomas E Gwise, FDA 

Keywords: predictive markers, adaptive designs

Scientific advancement foreshadows the development of new predictive markers for use in selecting patient treatments. In this presentation, we will review several clinical trial designs suggested for validating such markers and discuss the potential for using response adaptive randomization in similar investigations. Results of simulation studies based on available clinical trial data will be presented to illustrate characteristics of the adaptive designs in this setting.