| Pre-FDAAA | Post-FDAAA | ||||
---|---|---|---|---|---|---|
FDA interpretation of the trial results, no. (%) | FDA interpretation of the trial results, no. (%) | |||||
Positive (n = 72) | Equivocal (n = 16) | Negative (n = 13) | Positive (n = 35) | Equivocal (n = 1) | Negative (n = 5) | |
Published, interpretation agrees with FDA’s | 72 (100%) | 9 (56%) | 3 (23%) | 35 (100%) | 0 (0%) | 5 (100%) |
Published, interpretation does not agree with FDA’s | 0 (0%) | 5 (31%) | 2 (13%) | 0 (0%) | 1 (100%) | 0 (0%) |
Not published | 0 (0%) | 2 (13%) | 8 (62%) | 0 (0%) | 0 (0%) | 0 (0%) |