Study and Clin Trials Design

2 Credits · Level: Graduate

This course builds upon the introductory statistics concepts and skills developed in the first term, extending them to practical application in study and clinical trial design and interpretation. Topics include structural aspects of clinical trials, protocol design, randomization and blinding, issues of error, bias and hypothesis testing, selecting and working with trial outcome variables, issues in safety versus efficacy trials, power and sample size calculations, secondary subgroup and exploratory analysis.