Table 2.
Trial characteristic
| All | BF | OT | Availability* | |
|---|---|---|---|---|
| (n = 245, 100 %) | (n = 147, 60 %)b | (n = 98, 40 %)c | BF vs OT** | |
| Trial phase | ||||
| Data not availablea | 44 (18.0 %) | 34 (23.1 %) | 10 (10.2 %) | 0.010* |
| Phase 0 | 1 (0.5 %) | 1 (0.9 %) | 0 (0.0 %) | 0.005** |
| Phase 1 | 33 (16.4 %) | 13 (11.5 %) | 20 (22.7 %) | |
| Phase 1/Phase 2 | 16 (8.0 %) | 10 (8.8 %) | 6 (6.8 %) | |
| Phase 2 | 79 (39.3 %) | 47 (41.6 %) | 32 (36.4 %) | |
| Phase 2/Phase 3 | 4 (2.0 %) | 4 (3.5 %) | 0 (0.0 %) | |
| Phase 3 | 55 (27.4 %) | 26 (23.0 % | 29 (33.0 %) | |
| Phase 4 | 13 (6.5 %) | 12 (10.6 %) | 1 (1.1 %) | |
| Number of trial arms | ||||
| Data not availablea | 48 (19.6 %) | 28 (19.0 %) | 20 (20.4 %) | 0.793* |
| 1 | 110 (55.8 %) | 71 (59.7 %) | 39 (50.0 %) | 0.081** |
| 2 | 74 (37.6 %) | 43 (36.1 %) | 31 (39.7 %) | |
| 3 | 6 (3.0 %) | 2 (1.7 %) | 4 (5.1 %) | |
| 4 | 6 (3.0 %) | 3 (2.5 %) | 3 (3.8 %) | |
| 5 | 1 (0.5 %) | 0 (0.0 %) | 1 (1.3 %) | |
| Enrollment (No of patients) | ||||
| Data not availablea | 2 (0.8 %) | 9 (6.1 %) | 7 (7.1 %) | 0.751* |
| 1–50 | 105 (43.2 %) | 65 (44.8 %) | 40 (40.8 %) | 0.184** |
| 51–100 | 40 (16.5 %) | 26 (17.9 %) | 14 (14.3 %) | |
| 101–200 | 27 (11.1 %) | 15 (10.3 %) | 12 (12.2 %) | |
| 201–500 | 30 (12.3 %) | 20 (13.8 %) | 10 (10.2 %) | |
| >500 | 41 (16.9 %) | 19 (13.1 %) | 22 (22.4 %) | |
| Intervention model | ||||
| Data not availablea | 40 (16.3 %) | 18 (12.2 %) | 22 (22.4 %) | 0.034* |
| Single Group Assignment | 124 (60.5 %) | 84 (65.1 %) | 40 (52.6 %) | 0.075** |
| Parallel Assignment | 78 (38.0 %) | 42 (32.6 %) | 36 (47.4 %) | |
| Factorial Assignment | 2 (1.0 %) | 2 (1.6 %) | 0 (0 %) | |
| Crossover Assignment | 1 (0.5 %) | 1 (0.8 %) | 0 (0 %) | |
| Endpoint classification | ||||
| Data not availablea | 74 (30.2 %) | 38 (25.9 %) | 36 (36.7 %) | 0.069* |
| Safety Study | 18 (10.5 %) | 5 (4.6 %) | 13 (21.0 %) | 0.002** |
| Efficacy Study | 60 (35.1 %) | 42 (38.5 %) | 18 (29.0 %) | |
| Safety/Efficacy Study | 91 (53.2 %) | 61 (56.0 %) | 30 (48.4 %) | |
| Bio-equivalence Study | 1 (0.6 %) | 1 (0.9 %) | 0 (0.0 %) | |
| Pharmacodynamics Study | 1 (0.6 %) | 0 (0 %) | 1 (1.6 %) |
aPercents of total number per column
bBrachytherapy in focus
cOther trials
* p value for availability of data between groups
** p value for test between BF and OT (without unavilable data)