Table 3 Factors influencing median time from ethics submission to ethics approval (days) for 150 site activations
Median (range) | Univariable p-value* Multivariable p-value** | |
|---|---|---|
Overall | 48 (0, 369) | |
Phase | ||
1 (n = 17) | 15 (5, 106) | 0.028* |
2 (n = 27) | 41 (16, 139) | 0.7** |
3 (n = 98) | 61 (0, 369) | |
4 (n = 8) | 49 (2, 49) | |
Disease area of trial | ||
Nephrology (n = 54) | 49 (2, 139) | < 0.001* |
Oncology (n = 40) | 21 (3, 106) | 0.054** |
Endocrinology (n = 24) | 97 (0, 203) | |
Neurology (n = 22) | 41 (16, 99) | |
Paediatrics (n = 10) | 96 (20, 369) | |
Country | ||
Australia (n = 126) | 48 (0, 369) | 0.094* |
South Korea (n = 10) | 46 (11, 75) | NA** |
Hong Kong SAR (n = 5) | 86 (35, 105) | |
Taiwan (n = 5) | 32 (32, 32) | |
New Zealand (n = 4) | 63 (63, 63) | |
Trial site ownership | ||
Government (n = 108) | 48 (0, 369) | > 0.9* |
Private (n = 18) | 46 (8, 215) | 0.2** |
Unknown (n = 24) | 54 (11, 105) | |
Scope guidelines for ethics review | ||
Yes (n = 116) | 38 (0, 369) | < 0.001* |
No (n = 34) | 88 (41, 215) | 0.2** |
Mutual acceptance of other ethics committee approvals | ||
Yes (n = 79) | 34 (0, 369) | < 0.001* |
No (n = 55) | 67 (13, 215) | 0.65** |
Unknown (n = 16) | 18 (6, 125) | |
Triage by low, medium, or high risk | ||
Yes (n = 96) | 38 (0, 369) | < 0.001* |
No (n = 49) | 67 (3, 215) | 0.4** |
Unknown (n = 5) | 31 (15, 99) | |
COVID-19 pandemic | ||
Pre-pandemic (n = 114) | 44 (0, 369) | 0.5* |
During or after pandemic (n = 36) | 49 (2, 139) | 0.8** |