Clinical Trials.

Catalog description

Semester course; 3 lecture hours (delivered online or face-to-face). 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.