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. 

• 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

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