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Fig. 3 | Trials

Fig. 3

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

Fig. 3

Publication status and publication-FDA agreement of neuropsychiatric Trials by FDAAA applicability and by trial results. Overall, more post-FDAAA trials were published (100% vs 90%; p = 0.06) and the publications were in agreement with the FDA’s interpretation (98% vs 93%; p = 0.28), but neither outcome was significant. When stratified by results, trials with positive results were all published during both pre-FDAAA (72 of 72) and post-FDAAA (35 of 35). When trials with negative results were examined in isolation, the publication rate was significantly higher after FDAAA as compared to before (5 of 5 vs 5 of 13; p = 0.04). There were not enough equivocal trials to draw comparison. All comparisons were based on two-tailed Fisher exact tests

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