[NC State Home] Department of Statistics
 

Recent Instructors
Zhang, Daowen
ST 520 Statistical Principles of Clinical Trial and Epidemiology

Course Description

This course will introduce some basic statistical concepts and methods used in Epidemiology and will focus on the statistical principles and methods used in clinical trials, including Phase I to IV clinical trials, with emphasis on phase III trials. We will discuss ways of treatment allocation that will ensure valid inference on treatment comparision. Other topics include sample calculation, survival analysis and early stopping of a clinical trial.

Course Syllabus

  • Introduction
    • Introcution to Epidemiology
    • Introduction to History of Clinical Trials
    • Phase I and II Clinical Trials
    • Phase III Clinical Trials
    • Randomization
      • Design-based Inference
      • Fixed Allocation Randomization
      • Adaptive Randomization Procedures
      • Response Adaptive Randomization
      • Mechanics of Randomization
      • Additional Phase III clinical trails
        • Blinding and Placebos
        • Ethics
        • Protocol Document
      • Sample Size Calculations
      • Comparing More than Two Treaments
      • Causality, Non-compliance and Intent-to-treat
      • Survival Analysis in Phase III Clinical Trials.
    • Course Prerequisites
      • ST 511
      Course Corequisites
      • ST 512
      Recent Textbooks
      • None

[line]

Last Modified May 2006