Table 2 IRB members’ opinions of justifications for unbalanced randomization by class of perception of unbalanced randomization
Justifications for unbalanced randomizationa | Total (n = 148) | Class 1b (n = 58) | Class 2 (n = 46) | Class 3 (n = 44) |
|---|---|---|---|---|
Gaining experience with the treatment | ||||
Justification considered acceptable | 6.1 ± 3.3 | 3.2 ± 2.6 | 7.5 ± 2.6 | 8.2 ± 1.9 |
Justification considered ethically sound | 6.0 ± 3.4 | 4.1 ± 3.4 | 7.0 ± 3.0 | 7.5 ± 2.3 |
Cost issues | ||||
Justification considered acceptable | 3.2 ± 3.0 | 1.9 ± 1.6 | 4.8 ± 3.5 | 3.3 ± 3.2 |
Justification considered ethically sound | 3.1 ± 3.3 | 1.8 ± 2.2 | 3.9 ± 3.5 | 4.0 ± 3.6 |
Increasing patient acceptability | ||||
Justification considered acceptable | 5.4 ± 3.4 | 4.4 ± 3.2 | 7.5 ± 2.7 | 4.6 ± 3.3 |
Justification considered ethically sound | 5.2 ± 3.5 | 4.5 ± 3.5 | 6.7 ± 3.1 | 4.6 ± 3.4 |
Reduction in expected dropout | ||||
Justification considered acceptable | 5.7 ± 3.3 | 4.7 ± 3.4 | 7.0 ± 2.8 | 5.7 ± 3.3 |
Justification considered ethically sound | 6.0 ± 3.3 | 4.8 ± 3.4 | 7.6 ± 2.2 | 5.8 ± 3.4 |
Ethics issues (e.g., bad deal trial) | ||||
Justification considered acceptable | 3.6 ± 3.4 | 2.5 ± 2.5 | 6.4 ± 3.4 | 2.0 ± 2.1 |
Justification considered ethically sound | 2.7 ± 3.5 | 1.3 ± 2.2 | 5.8 ± 3.5 | 1.4 ± 2.6 |
Methodological reasons | ||||
Justification considered acceptable | 6.0 ± 3.3 | 5.1 ± 3.3 | 6.7 ± 3.2 | 6.4 ± 3.2 |
Justification considered ethically sound | 5.7 ± 3.4 | 4.9 ± 3.5 | 6.1 ± 3.3 | 6.3 ± 3.1 |