Table 4 Factors influencing time to governance submission to governance approval (days) for 145 site activations
Median (range) | Univariable p-value* Multivariable p-value** | |
|---|---|---|
Overall | 34 (0, 489) | |
Phase | ||
1 (n = 17) | 39 (0, 89) | 0.2* |
2 (n = 27) | 45 (1, 140) | 0.014** |
3 (n = 93) | 33 (0, 489) | |
4 (n = 8) | 18 (12, 99) | |
Disease area of trial | ||
Nephrology (n = 49) | 37 (0, 489) | 0.012* |
Oncology (n = 40) | 17 (0, 112) | 0.044** |
Endocrinology (n = 24) | 41 (3, 192) | |
Neurology (n = 22) | 47 (1, 140) | |
Paediatrics (n = 10) | 40 (21, 433) | |
Country | ||
Australia (n = 126) | 34 (0, 489) | 0.094* |
South Korea (n = 10) | 10 (0, 102) | NA** |
Hong Kong SAR (n = 5) | 62 (9, 87) | |
Taiwan (n = 0) | - | |
New Zealand (n = 4) | 30 (7, 56) | |
Trial site ownership | ||
Government (n = 108) | 35 (0, 489) | 0.3* |
Private (n = 18) | 28 (3, 77) | 0.032** |
Unknown (n = 19) | 14 (0, 102) | |
Scope guidelines used for the governance review | ||
Yes (n = 110) | 28 (0, 489) | < 0.001* |
No (n = 35) | 79 (3, 135) | 0.020** |
Triage by low, medium, or high risk | ||
Yes (n = 111) | 24 (0, 489) | < 0.001* |
No (n = 31) | 81 (29, 135) | 0.043** |
Unknown (n = 3) | 10 (6, 53) | |
COVID-19 pandemic | ||
Pre-pandemic (n = 109) | 31 (0, 192) | 0.12* |
During or after pandemic (n = 36) | 41 (7, 489) | 0.013** |