From: Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Number of studies (%) | Registered, n (%) | Odds ratio (95% CI), p value | Published, n (%)a | Odds ratio (95% CI), p value | Concordant interpretation, n (%)a | Odds ratio (95% CI), p value | |
---|---|---|---|---|---|---|---|
Overall | 183 (100) | 151 (83) | 169 (92) | 152 (90) | |||
Post FDAAA | |||||||
Therapeutic categoryb | |||||||
Cardiovascular disease | 21 (27) | 21 (100) | –, 1.00 | 19 (90) | –, 0.07 | 19 (100) | –, 1.00 |
Diabetes | 57 (73) | 57 (100) | 57 (100) | 55 (96) | |||
FDA review pathwayc | |||||||
Priority review | 9 (12) | 9 (100) | –, 1.00 | 9 (100) | –, 1.00 | 9 (100) | –, 1.00 |
Standard review | 69 (88) | 69 (100) | 67 (97) | 65 (97) | |||
Orphan statusc | |||||||
Yes | 6 (8) | 6 (100) | –, 1.00 | 6 (100) | –, 1.00 | 6 (100) | –, 1.00 |
No | 72 (92) | 72 (100) | 70 (97) | 68 (97) | |||
Trial designationd | |||||||
Pivotal | 57 (73) | 57 (100) | –, 1.00 | 55 (96) | –, 1.00 | 53 (96) | –, 1.00 |
Nonpivotal | 21 (27) | 21 (100) | 21 (100) | 21 (100) | |||
Trial phase | |||||||
Phase 2 | 10 (13) | 10 (100) | –, 1.00 | 10 (100) | –, 1.00 | 10 (100) | –, 1.00 |
Phase 3 | 68 (87) | 68 (100) | 66 (97) | 64 (97) | |||
Randomized design | |||||||
Yes | 74 (95) | 74 (100) | –, 1.00 | 72 (97) | –, 1.00 | 70 (97) | –, 1.00 |
No | 4 (5) | 4 (100) | 4 (100) | 4 (100) | |||
Double blinded | |||||||
Yes | 72 (92) | 72 (100) | –, 1.00 | 70 (97) | –, 1.00 | 68 (94) | –, 1.00 |
No | 6 (8) | 6 (100) | 6 (100) | 6 (100) | |||
Active comparator | |||||||
Yes | 32 (41) | 32 (100) | –, 1.00 | 32 (100) | –, 1.00 | 30 (94) | –, 1.00 |
No | 46 (59) | 46 (100) | 44 (96) | 44 (100) | |||
Trial duration | |||||||
≤ 12 weeks | 15 (19) | 15 (100) | –, 1.00 | 13 (87) | –, 0.04 | 13 (100) | –, 1.00 |
> 12 weeks | 63 (81) | 63 (100) | 63 (100) | 61 (97) | |||
Number of patients in trial | |||||||
< 500 | 31 (40) | 31 (100) | –, 1.00 | 30 (97) | 0.65 (0.04 to 10.83), 0.64 | 30 (100) | –, 0.52 |
≥ 500 | 47 (60) | 47 (100) | 46 (98) | 44 (96) | |||
Jadad score | |||||||
< 3 | 6 | 6 | –, 1.00 | 6 | –, 1.00 | 6 | –, 1.00 |
≥ 3 | 72 | 72 | 70 | 68 |