Table 2.
Overall publication status of human drug studies by study phase, with percentages based on proportion of submissions within study phase. Figures are number of studies; percentage (95% CI)
| All studies | Phase I | Phase II/IIA | Phase IIB | Phase III/IIIA | Phase IIIB | Phase IV | Phase NA | |
|---|---|---|---|---|---|---|---|---|
| Submitted: | ||||||||
| Published* | 751; 71 (68 to 73) | 219; 57 (52 to 62) | 95; 79 (70 to 85) | 45; 79 (67 to 88) | 100; 88 (81 to 93) | 46; 78 (66 to 87) | 93; 74 (66 to 81) | 153; 75 (69 to 80) |
| Pending | 100; 9 (8 to 11) | 28; 7 (5 to 10) | 11; 9 (5 to 16) | 7; 12 (6 to 23) | 9; 8 (4 to 14) | 10; 17 (9 to 28) | 14; 11 (7 to 18) | 21; 10 (7 to 15) |
| Rejected | 53; 5 (4 to 6) | 9; 2 (1 to 4) | 9; 7 (4 to 14) | 2; 4 (1 to 12) | 1; 1 (0 to 5) | 2; 3 (1 to 12) | 10; 8 (4 to 14) | 20; 10 (6 to 15) |
| Abstract | 77; 7 (6 to 9) | 69; 18 (14 to 22) | 2; 2 (0 to 6) | 0; 0 (0 to 6) | 2; 2 (0 to 6) | 1; 2 (0 to 9) | 2; 2 (0 to 6) | 1; <1 (0 to 3) |
| Not submitted | 83; 8 (6 to 10) | 60; 16 (12 to 20) | 4; 3 (1 to 8) | 3; 5 (2 to 14) | 1; 1 (0 to 5) | 0; 0 (0 to 6) | 6; 5 (2 to 10) | 9; 4 (2 to 8) |
| Total | 1064 | 385 | 121 | 57 | 113 | 59 | 125 | 204 |
NA=not applicable.
*Includes 48 studies accepted but not yet published as of data cut-off date.