ABSTRACT
Biomarker-guided treatment options are gaining in popularity due to the advanced knowledge of biomarkers and their value in stratifying a patient population that is otherwise more heterogeneous. Using the biomarker information, biomarker-informed designs provide a cost-effective way for clinical studies. Both adaptive and nonadaptive biomarker-informed designs were proposed in the last decade and have been widely used in many therapeutic areas. These designs have proven useful in accelerating drug approval and reducing resources consumed. In this section, case studies of biomarker-informed design from oncology and cardiovascular studies are discussed. Through these real-world examples, a drug developer may expect to gain a better understanding of these designs and their potential benefits to the clinical development.
