Question

1. A non-inferiority test is carried out to compare a new drug that comes with a claim of fewer side effects to the existing standard of care drug for shoulder injuries. Two comparisons of efficacy are done:
   1. The first efficacy comparison is on how quickly complete motor function is restored (Fewer number of days=better). Given a pre-specified margin of acceptance of 2 days, which of the following confidence intervals (point estimate: mean number of days for new drug - mean number of days for standard drug) would lead you to consider the new drug non-inferior to the standard? Briefly explain.
      1. (-5,-3)
      2. (-5,0)
      3. (0,3)
      4. (-3,4)
   2. The second efficacy comparison is on a motor activity assessment scale from 0 to 100 (higher=better). Given a pre-specified margin of acceptance of 10 units, which of the following confidence intervals (point estimate: mean activity assessment for new drug - mean activity assessment for standard drug) would lead you to consider the new drug non-inferior to the standard? Briefly explain.
      1. (-18,-11)
      2. (-11, 20)
      3. (2, 20)
      4. (-9,-3)

Answer 1

Solution: