Statistical Issues, Planning, And Analysis Of Contemporary Clinical Trials. 2 Credit Hours

Catalog description

This elective course will serve as an in-depth survey of the various clinical trial designs, analysis, and regulatory issues. Students will learn to apply statistical principles in designing clinical trials to minimize risk to patients while maximizing generalizable discovery. Specific topics include Phase I-V studies, adaptive designs, longitudinal and survival studies. Students will learn to specify the primary outcome and to estimate the required sample size for common trial designs. Clinical trial design and analysis is often complicated by idiosyncrasies such as missing data, and the methodology for handling these will be covered. Prerequisites: TSCI 5072 and TSCI 6061 .