BIOS 571. Clinical Trials. 3 Hours.

Semester course; 3 lecture hours. 3 credits. Concepts of data management and statistical design and analysis in single-center and multicenter clinical trials. Data management topics include the collection, edition, and validation of data. Statistical design topics include randomization, stratification, blinding, placebo- and active-control groups, parallel and crossover designs, and power and sample size calculations. Statistical analysis topics include sequential and group sequential methods.