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Table 3 Publication and publication-FDA agreement of trials supporting FDA approval of NDAs with neuropsychiatric indications with positive, equivocal, and negative results

From: Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study

  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%)
  1. Trials were classified as positive, negative, or equivocal based on the FDA’s interpretation of the results. Published interpretation of the trial with the FDA’s interpretation for each trial. The two were considered in agreement if the interpretations were both categorized as positive, negative, or equivocal, and no major contradictions existed between the two statements. Negative and equivocal trials were combined into a single group as non-positive trials when calculating publication bias