All Times EDT
Keywords: Precision medicine, Biomarker, Adaptive Designs, Simon's Two-Stage
Precision medicine utilizing biomarkers is an expanding area which tailors therapies for specific subgroups of patients with enhanced therapeutic effectiveness. Many phase II clinical trial designs integrating biomarkers have been proposed and conducted, to test a biomarker’s clinical utility in patient subgroup classification. In this project, three adaptive biomarker guided designs are reviewed and compared for binary endpoints. The primary criterion is to maximize the power given specific sample sizes and type I errors. The best design framework is then extended to survival endpoints. In this design framework, two decision methods are compared by simulation studies. Designs are coded to support future phase II trials.