Clinical Trials and Experimental Design

3 credits · Graduate School

This course is an introduction to statistical aspects of the design, monitoring, and analysis of experiments. Emphasis is on studies of human subjects (i.e., clinical trials). Topics include study designs, randomization and balance, selection of estimands and endpoints, sample size projections, data collection and quality control, data monitoring and interim analysis, principles of and issues in the analysis of trial data, and interpretation and reporting of results. Prerequisites: BIOS 6301 or equivalent, BIOS 6311 or equivalent. [3]