Advancing cancer drug development through precision medicine and innovative designs. Issue 2 (4th March 2018)

• Record Type: Journal Article
• Authors: Zhang, Weidong; Wang, Jing; Menon, Sandeep
• Is Part Of: Journal of biopharmaceutical statistics. Volume 28:Issue 2(2018)
• Page Start: 229
• Page End: 244
• Publication Date: 2018-03-04
• Subjects: Biomarker -- cancer -- clinical trial design -- omics -- precision medicine; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2017.1402784
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: 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.