He has developed many of the statistical methods used in cancer clinical trials including dynamically stratified randomization, optimal 2 stage phase 2 clinical trial designs, accelerated titration phase 1 designs, stochastic curtailment for futility monitoring, tests of qualitative treatment by covariate interactions, predictive biomarker based enrichment designs, adaptive biomarker driven clinical trial designs and Bayesian methods for subset analysis, factorial clinical trials, and active control clinical trials. Dr. Simon is a leader in the development and use of predictive biomarkers in therapeutic research.