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Table 2 Trial characteristic

From: Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

  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 %)
  1. aPercents of total number per column
  2. bBrachytherapy in focus
  3. cOther trials
  4. * p value for availability of data between groups
  5. ** p value for test between BF and OT (without unavilable data)