Welcome to STAT 509!

About this Course

Welcome to the course notes for STAT 509: Design and Analysis of Clinical Trials. These notes are designed and developed by Penn State's Department of Statistics and offered as open educational resources. These notes are free to use under Creative Commons license CC BY-NC 4.0.

This course is part of the Online Master of Applied Statistics program offered by Penn State's World Campus.

Currently enrolled?

If you are a current student in this course, please see Canvas for your syllabus, assignments, lesson videos and communication from your instructor.

How to enroll?

If you would like to enroll and experience the entire course for credit please see 'How to enroll in a course' on the World Campus website.

Course Overview Section

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