ABSTRACT
Biomarker-informed clinical trials provide efficiencies in drug development. These trials rely on predictive values of biomarkers that can be used for identification of patient subpopulation in regards to drug response or safety. Novel clinical designs leveraging biomarker information have been widely adopted in many therapeutic areas, particularly in oncology. In this section, we provide a review of novel clinical designs, including different variations of adaptive designs, basket designs and umbrella designs using predictive biomarkers.
