Table 3 Responses for the ethical considerations of unbalanced randomization by class of perception of unbalanced randomization
Ethical considerations of unbalanced randomizationa | Total (n = 148) | Class 1b (n = 58) | Class 2 (n = 46) | Class 3 (n = 44) |
|---|---|---|---|---|
Increase in sample size is ethically acceptable | 6.1 ± 3.1 | 5.2 ± 2.8 | 7.2 ± 2.7 | 5.9 ± 3.4* |
Non-inferiority trials raise distinct issues regarding unbalanced randomization | 5.6 ± 3.0 | 5.4 ± 2.9 | 5.6 ± 3.0 | 5.8 ± 3.0 |
Unbalanced randomization respects equipoise | 4.5 ± 3.3 | 3.6 ± 2.9 | 5.5 ± 3.5 | 4.8 ± 3.2* |
Beginning a trial with previous negative and positive trial results in equal proportion is ethical | 6.2 ± 2.8 | 6.2 ± 2.6 | 6.8 ± 3.1 | 5.4 ± 2.8 |
Equipoise exists with an equal proportion of negative and positive trials before beginning a new trial | 6.0 ± 3.2 | 5.5 ± 3.3 | 6.9 ± 3.2 | 5.8 ± 3.0 |