Non-inferiority Clinical Trial Principles illustrated by different
scenarios (1–6), where the effects of an active control and experimental
treatment are within the confidence intervals (along the x-axis).
1) Experimental non-inferior to control but not significantly different
from active control.
2) Experimental is non-inferior to control but is significantly
different from control.
3) Experimental is somewhat inferior to control. Experimental is not
inferior because the CI does not include the non-inferior margin or the line of
Δ0.
4) Inconclusive because the CI includes values on both sides of the
non-inferiority margin and the line of no treatment difference (Δ0).
5) Experimental is inferior to control because it includes the
non-inferiority margin.
6) Experimental is inferior to control and is more certain of its
inferiority as compared to scenario (5) because it does not include the
non-inferiority margin.