Table 1 Summary of conduct of MANI trials
No. of MANI trials assessed | 65 |
|---|---|
Trial background and setup | |
 No. trials with authors from primarily academic/industry backgrounds | 56/9 |
 No. trials with funding primarily from non-industry/industry sources | 25/40 |
 No. single centre/multi centre trials | 10/55 |
 No. with NI primary/key secondary endpoint | 58/7 |
Design considerations | |
 No. of trials that implemented a fixed margin approach (as outlined by FDA) | 61 |
 No. of trials that included a placebo arm | 7 |
 No. of trials that implemented a method to optimise sample size | 1 |
Multiple testing | |
 No. of trials where adjustment was required for multiple testing | 39 |
 No. of trials where adjustment was made for multiple testing | 31 |
 No. of trials adjusted with a closed testing procedure | 14 |
 No. of trials implementing Bonferroni adjustment | 12 |
 No. of trials implementing other methods of adjustment for multiple testing | 5 |
 No. of trials where superiority tested after NI proven | 15 |
Analysis considerations | |
 No. where heterogeneous treatment variance mentioned | 0 |
 No. of trials that clearly defined a choice of power | 35 |
 No. of trials that used all pair power/any pair power | 11/24 |
Data type | |
 No. trials with continuous MANI endpoint | 34 |
 No. trials with binary MANI endpoint | 22 |
 No. trials with survival MANI endpoint | 9 |