Enrolled students may access all course materials on Canvas.

Course Description:

Statistical analysis is critical for evaluating the success of clinical trials of drugs and devices.  This graduate level course provides a conceptual overview of experimental design, statistical analysis, and interpretation of results of statistical analysis for nonstatisticians who are managing clinical trials.  The focus is on concepts although you will learn formulas and calculations as needed to develop a conceptual understanding.

Course Learning Outcomes:

Upon successful completion of the course, students will be able to:

• Explain the role of statistics in clinical trials
• Use basic statistical terminology
• Formulate and identify research and statistical hypotheses
• Understand experimental designs commonly used in clinical trials
• Describe clinical trials concepts such as bias, randomization, blinding, power, and sample size
• Identify different types of outcomes and endpoints
• Understand how descriptive statistics are used to summarize data
• Understand probability, odds, distributions, statistical errors, p-values, and statistical significance
• Understand the purpose of statistical tests commonly used in clinical trials
• Interpret the meaning of the results of statistical tests
• Comfortably communicate with statisticians about the results of statistical tests