Table 1.

Guidelines for reporting equivalence/noninferiority trials. (From Gomberg-Maitland et al).

1. A table comparing the inclusion and exclusion criteria with those of previous trials on which the standard therapy was based.

2. A flow diagram delineating the number of eligible patients screened, the number randomised, the number of patients assigned to each group, the number of withdrawals and crossovers, and the number of patients in each group who successfully completed the trial on assigned treatment.

3. A statement on the projected and actual total treatment exposure (patient-years), the minimum per-patient exposure, and the respective impact of withdrawals and crossovers on exposure to initially assigned treatment.

4. The rationale of setting the margin of acceptable difference with specific reference to the minimum clinically important treatment effect and with the established efficacy advantage for the control over placebo. Where event rate ratios or floating margins are utilized, the rationale for their use, their prespecified criteria for adjustment, and the margin or ratios used to determine sample size should be provided.

5. The minimum requisite number of primary events should be established at the outset.

6. A comparison of event rates during treatment with the active control in the trial and in the historical trials that established its efficacy compared with placebo.