Precision medicine has been a hot topic in drug development over the last decade. Biomarkers have been proven useful for understanding the disease progression and treatment response in precision medicine development. Advancement of high-throughput omics technologies has enabled fast identification of molecular biomarkers with low cost. Although biomarkers have brought many promises to drug development, steep challenges arise due to a large amount of data, complexity of technology, and lack of full understanding of biology. In this article, we discuss the technologies and statistical issues that are related to omics biomarker discovery. We also provide an overview of the current development of biomarker-enabled cancer clinical trial designs.
Keywords: Biomarker; cancer; clinical trial design; omics; precision medicine.