Statistical Design and Analysis of Clinical Trials - STA 545

Course Objectives

The objectives of the course are to introduce the essential components of the biostatistics component of a clinical trial protocol. The broad goals for Phase I, Phase II, and Phase III non-cancer trials as well as oncology trials are explored. Statistical software, such as R and SAS, are used to calculate the statistical properties of these trials. 

Course Topics

  • Ethical aspects and basic concepts of randomized controlled trials (RCTs)
  • Crossover Designs
  • Sample size and power calculations for a given trial
  • Non-inferiority, Equivalence, and Superiority trials
  • Phase I vaccine trials
  • Phase I trials in cancer
  • Phase II trials in cancer
  • Phase III randomized, placebo-controlled trials
  • Group sequential methods
  • Adaptive designs and sample size reestimation
  • Meta-analysis of RCTs and Prevention Trials

Example Syllabus