Table 1.
Credible interval (BCI) |
Toxicity monitoring |
Model-based designs |
Model-assisted designs |
No specified Bayesian approach |
Total |
p value | |
---|---|---|---|---|---|---|---|
No. (%) | No. (%) | No. (%) | No. (%) | No. (%) | No. (%) | ||
Phase | |||||||
Early Phase | 16 (100.0) | 57 (96.6) | 63 (98.4) | 18 (100.0) | 60 (98.2.0) | 214 (95.1) | 0.05 |
Late phase | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (7.4) | 5 (2.2) | |
Not Applicable | 0 (0.0) | 2 (3.4) | 1 (1.6) | 0 (0.0) | 3 (4.4) | 6 (2.7) | |
Interventional model | |||||||
Single group assignment | 8 (50.0) | 48 (81.4) | 39 (60.9) | 13 (72.2) | 39 (57.4) | 147(65.3) | 0.00 |
Paralell | 8 (50.0) | 11 (18.6) | 18 (28.1) | 1 (5.6) | 26 (38.2) | 64 (28.4) | |
Sequential assignment | 0 (0.0) | 0 (0.0) | 7 (10.9) | 4 (22,2) | 2 (2.9) | 13 (5.8) | |
Crossover | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 1 (0.4) | |
Masking | |||||||
Open label | 16 (100.0) | 59 (100.0) | 62 (96.9) | 18 (100.0) | 65 (95.6) | 220(97.8) | 0.44 |
Single blinded | 0 (0.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 1 (0.4) | |
Double blinded | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (4.4) | 3 (1.3) | |
Triple blinded | 0 (0.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 1 (0.4) | |
Allocation | |||||||
Non-randomized | 4 (25.0) | 9 (15.3) | 26 (40.6) | 4 (22.2) | 13 (9.1) | 56 (24.9) | 0.00 |
Randomized | 4 (25.0) | 4 (6.8) | 8 (12.5) | 1 (5.6) | 22 (32.4) | 39 (17.3) | |
Not applicable | 8 (50,0) | 46 (78.0) | 30 (46.9) | 13 (72.2) | 33 (48.5) | 130(57.8) | |
Purpose | |||||||
Treatment | 15 (93.8) | 58 (98.3) | 62 (96.9) | 17 (94.4) | 65 (95.6) | 217(96.4) | 0.66 |
Supportive care | 0 (0.0) | 1 (1.7) | 1 (1.6) | 1 (5.6) | 0 (0.0) | 3 (1.3) | |
Diagnostic | 1 (6.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 2 (0.9) | |
Prevention | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 1 (0.4) | |
Other | 0 (0.0) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 1 (1.5) | 2 (0.9) | |
Main outcome | |||||||
Efficacy | 16 (100.0) | 39 (66.1) | 14 (21.9) | 0 (0.0) | 40 (58.8) | 109(48.4) | 0.00 |
Toxicity | 00 (0.0) | 12 (20.3) | 37 (57.8) | 6 (33.3) | 16 (23.5) | 71(31.6) | |
Dose finding | 0 (0.0) | 8 (13.6) | 13 (20.3) | 12 (66.7) | 12 (17.6) | 45 (20.0) | |
Intervention | |||||||
Drug | 10 (62.5) | 41 (69.5) | 44 (68.8) | 12 (66.7) | 53 (77.9) | 160(71.1) | 0.09 |
Biological | 1 (6.3) | 9 (15.3) | 13 (20.3) | 2 (11.1) | 5 (7.4) | 30(13.3) | |
Procedure | 2 (12.5) | 1 (1.7) | 5 (7.8) | 3 (16.7) | 4 (5.9) | 15 (6.7) | |
Radiation | 0 (0.0) | 3 (5.1) | 1 (1,6) | 0 (0.0) | 4 (5.9) | 8 (3.6) | |
Behavioral | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 1 (0.4) | |
Device | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 1 (0.4) | |
Other | 3 (18.8) | 5 (8.5) | 1 (1.6) | 1 (5.6) | 0 (0.0) | 10 (4.4) | |
Total | 16 (7.1) | 59(26.2) | 64(28.4) | 18(8.0) | 68(30.2) | 225 (100.0) |