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. 2017 Sep 5;33(1):88–96. doi: 10.1007/s11606-017-4161-4

Figure 1.

Figure 1

Simulacrum of the CONSORT diagram for interpreting the results of noninferiority trials. According to CONSORT, noninferiority can be declared whenever the upper bound of the confidence interval of the difference between the two therapies does not include delta, as in scenarios 1–4. Whenever the upper bound of the confidence interval exceeds delta, as in scenarios 5–7, noninferiority cannot be declared, because the plausible values of the parameter include some values greater than delta. When both the upper and lower bounds of the confidence interval exceed delta, the NT is declared inferior to the AC, as in scenario 8. Scenario 1 represents all situations in which the upper bound of the confidence interval is less than zero—that is, any statistically significant result favoring the NT garners a declaration of superiority for the NT. By contrast, in scenarios 4 and 7, where there is a statistically significant difference favoring the AC, the NT is not declared inferior in this schematic, but rather noninferior (scenario 4) or inconclusive (scenario 7). NT, new treatment; AC, active control; Δ, delta (the pre-specified margin of noninferiority).