STAT 509: Design and Analysis of Clinical Trials

This is a graduate level survey course that stresses the concepts of statistical design and analysis in biomedical research, with special emphasis on clinical trials. SAS for Windows statistical software will be used throughout the course for data analysis.

This course is a survey of statistical methods and study design issues related to the testing of medical treatments. There are 19 lessons in this graduate level course that cover the following topics:

• Ethical Considerations
• Clinical Trial Designs
• Bias and Random Error
• Objectives and Endpoints
• Sample Size and Power
• The Study Cohort
• Treatment Allocation and Randomization
• Interim Analyses and Stopping Rules
• Missing Data and Intent-to-Treat
• Estimating Clinical Events
• Prognostic Factors and Regression Models
• Reporting and Publishing
• Factorial Designs
• Cross-Over Designs
• Overviews and Meta-Analysis
• Diagnostic Testing
• Measures of Agreement