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