About
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.
Course Topics
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
Course Author(s)
Rebecca Lengerich has been involved in teaching this course and brings extensive experience from her work as Senior Instructor, Health Evaluation Sciences at Penn State's College of Medicine. She has recently added a considerable amount of interaction to the course materials.
Software
In order to take this course, you need:
- access to a Windows PC that has internet access, SAS, and Microsoft Word
Textbook
The required textbook for this course is:
Friedman, Lawrence M. (2015). Fundamentals of Clinical Trials. 5th Edition, Springer. ISBN: 978-3-319-18538-5
Assessment Plan
- 7 Check Your Understanding Quizzes – (33 points)
- 4 Homework Assignments – (80 points)
- 7 Discussion Activities – (37 points)
- 1 Final Exam – (50 points)