6b.9 - Summary

In this lesson, among other things, we learned:

• Distinguish between superiority, non-inferiority and equivalence trials in terms of
  • objectives
  • control group
  • hypotheses tested and
  • formation of confidence intervals.
• Recognize the characteristics of a clinical trial with high external validity
• Define which data are included in an intention-to-treat analysis
• Recognize the major considerations for designing an equivalence or non-inferiority trial.
• Perform sample size calculations for some equivalence and non-inferiority trials, using SAS programs.