Design of Clinical Trials

4.0 credits

Introduction to the principles of clinical trials; clinical trial protocols; overview of the drug development process; hypotheses/objectives; specification of response variables; defining the study population; randomization; blinding; ethical issues; factorial designs; crossover designs; equivalence trials; trial monitoring and interim analyses; sample size and power; issues in data analysis and reporting; evaluating clinical trial reports. Prerequisite: BST 463 or equivalent