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Table 2 Characteristics of 142 efficacy trials supporting FDA approval of NDAs for neuropsychiatric conditions, 2005–2014

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

  No. (%) (n = 142) No. registered (%) No. results reported (%) No. published (%)
FDAAA applicability
 Pre-FDAAA 101 (71%) 65 (64%) 10 (10%) 91 (90%)
 Post-FDAAA 41 (29%) 41 (100%) 41 (100%) 41 (100%)
Pivotal status
 Pivotal 92 (65%) 78 (85%) 40 (43%) 90 (98%)
 Non-pivotal 50 (35%) 28 (56%) 11 (22%) 8 (84%)
Study location
 All USA 65 (46%) 50 (77%) 14 (22%) 61 (94%)
 Some USA 54 (38%) 41 (76%) 29 (54%) 48 (89%)
 None USA 23 (16%) 15 (65%) 8 (35%) 23 (100%)
Study phase
 Phase II 33 (23%) 17 (52%) 7 (21%) 28 (85%)
 Phase III 105 (74%) 87 (83%) 44 (42%) 102 (97%)
 Phase II/III 4 (3%) 2 (50%) 0 (0%) 2 (50%)
Randomization
 NA (single-group) 5 (4%) 2 (40%) 0 (0%) 5 (100%)
 Randomized 136 (96%) 103 (76%) 51 (37%) 126 (93%)
 Non-randomized 1 (1%) 1 (100%) 0 (0%) 1 (100%)
Blinding
 Double-blinded 135 (95%) 102 (76%) 51 (37%) 125 (92%)
 Open-label 7 (5%) 4 (57%) 0 (0%) 7 (100%)
Comparators
 Placebo only 94 (66%) 70 (74%) 42 (45%) 86 (91%)
 Active comparator only 8 (6%) 5 (63%) 1 (13%) 7 (88%)
 Placebo and active comparator 29 (20%) 23 (79%) 6 (21%) 28 (97%)
 Lower-dose comparator only 4 (3%) 4 (100%) 2 (50%) 4 (100%)
 No comparator 7 (5%) 4 (57%) 0 (0%) 7 (100%)