Table 2.
Trial characteristics and designs for phase II–phase III trials in different years.
| Category | Information |
2013 (N = 57) |
2014 (N = 313) |
2015 (N = 90) |
2016 (N = 34) |
2017 (N = 43) |
2018 (N = 38) |
2019 (N = 66) |
2020 (N = 54) |
2021 (N = 65) |
|---|---|---|---|---|---|---|---|---|---|---|
| Allocation | Randomized, n (%) | 57 (100.0%) | 310 (99.0%) | 88 (97.8%) | 34 (100.0%) | 42 (97.7%) | 37 (97.4%) | 66 (100.0%) | 53 (98.1%) | 65 (100.0%) |
| Not randomized, n (%) | 0 (0.0%) | 3 (1.0%) | 2 (2.2%) | 0 (0.0%) | 1 (2.3%) | 1 (2.6%) | 0 (0.0%) | 1 (1.9%) | 0 (0.0%) | |
| Intervention model | Parallel Assignment, n (%) | 57 (100.0%) | 306 (97.8%) | 88 (97.8%) | 33 (97.1%) | 41 (95.3%) | 37 (97.4%) | 66 (100.0%) | 53 (98.1%) | 65 (100.0%) |
| Crossover Assignment, n (%) | 0 (0.0%) | 2 (0.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Single Group Assignment, n (%) | 0 (0.0%) | 4 (1.3%) | 2 (2.2%) | 0 (0.0%) | 2 (4.7%) | 1 (2.6%) | 0 (0.0%) | 1 (1.9%) | 0 (0.0%) | |
| Factorial Assignment, n (%) | 0 (0.0%) | 1 (0.3%) | 0 (0.0%) | 1 (2.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Masking | Double blind, n (%) | 56 (98.2%) | 298 (95.2%) | 86 (95.6%) | 31 (91.2%) | 40 (93.0%) | 35 (92.1%) | 62 (93.9%) | 52 (96.3%) | 65 (100.0%) |
| Single blind, n (%) | 1 (1.8%) | 8 (2.6%) | 2 (2.2%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.5%) | 0 (0.0%) | 0 (0.0%) | |
| Open label, n (%) | 0 (0.0%) | 7 (2.2%) | 2 (2.2%) | 3 (8.8%) | 3 (7.0%) | 3 (7.9%) | 3 (4.5%) | 2 (3.7%) | 0 (0.0%) | |
| Test scope | Domestic, n (%) | 57 (100.0%) | 313 (100.0%) | 90 (100.0%) | 34 (100.0%) | 43 (100.0%) | 37 (97.4%) | 66 (100.0%) | 54 (100.0%) | 63 (96.9%) |
| International Multi-center, n (%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 2 (3.1%) | |
| Numbers of group | One group, n (%) | 0 (0.0%) | 2 (0.6%) | 1 (1.1%) | 0 (0.0%) | 2 (4.7%) | 2 (5.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Two group, n (%) | 31 (54.4%) | 160 (51.1%) | 44 (48.9%) | 14 (41.2%) | 16 (37.2%) | 12 (31.6%) | 34 (51.5%) | 24 (44.4%) | 36 (55.4%) | |
| Three group, n (%) | 25 (43.9%) | 128 (40.9%) | 35 (38.9%) | 15 (44.1%) | 20 (46.5%) | 18 (47.4%) | 26 (39.4%) | 23 (42.6%) | 21 (32.3%) | |
| ≥Four group, n (%) | 1 (1.8%) | 23 (7.3%) | 10 (11.1%) | 5 (14.7%) | 5 (11.6%) | 6 (15.8%) | 6 (9.1%) | 4 (7.4%) | 8 (12.3%) | |
| Control assignment | Placebo control only, n (%) | 37 (64.9%) | 198 (63.3%) | 64 (71.1%) | 24 (70.6%) | 31 (72.1%) | 22 (57.9%) | 51 (77.3%) | 44 (81.5%) | 55 (84.6%) |
| Positive control only, n (%) | 10 (17.5%) | 71 (22.7%) | 13 (14.4%) | 4 (11.8%) | 3 (7.0%) | 2 (5.3%) | 11 (16.7%) | 5 (9.3%) | 2 (3.1%) | |
| Both, n (%) | 7 (12.3%) | 36 (11.5%) | 7 (7.8%) | 3 (8.8%) | 3 (7.0%) | 9 (23.7%) | 2 (3.0%) | 2 (3.7%) | 6 (9.2%) | |
| Neither, n (%) | 3 (5.3%) | 8 (2.6%) | 6 (6.7%) | 3 (8.8%) | 6 (14.0%) | 5 (13.2%) | 2 (3.0%) | 3 (5.6%) | 2 (3.1%) | |
| Sample sizes | ≤ 100 cases, n (%) | 2 (9.5%) | 21 (6.7%) | 9 (10.0%) | 5 (14.7%) | 4 (9.3%) | 5 (13.2%) | 5 (7.6%) | 6 (11.1%) | 6 (9.5%) |
| 101–300 cases, n (%) | 13 (61.9) | 176 (56.2%) | 52 (57.8%) | 18 (52.9%) | 29 (67.4%) | 23 (60.5%) | 54 (81.8%) | 44 (81.5%) | 46 (73.0%) | |
| 301–1000 cases, n (%) | 6 (28.6%) | 78 (24.9%) | 29 (32.2%) | 11 (32.4%) | 10 (23.3%) | 10 (26.3%) | 7 (10.6%) | 3 (5.6%) | 10 (15.9%) | |
| >1000 cases, n (%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.9%) | 1 (1.6) | |
| Sample sizes | Median (IQR) | 240 (180–432) | 240 (216–432) | 240 (180–480) | 240 (144–360) | 240 (144–294) | 240 (180–354) | 222 (120–240) | 216 (120–240) | 216 (138–240) |