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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:
a. 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 and select all that apply.
i. (-5,-3)
ii. (-5,0)
iii. (0,3)
iv. (-3,4)
b. 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 and select all that apply.
i. (-18,-11)
ii. (-11, 20)
iii. (2, 20)
iv. (-9,-3)

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A non-inferiority test is carried out to compare a new drug that com.pdf

  • 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: a. 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 and select all that apply. i. (-5,-3) ii. (-5,0) iii. (0,3) iv. (-3,4) b. 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 and select all that apply. i. (-18,-11) ii. (-11, 20) iii. (2, 20) iv. (-9,-3)