Table 2 Factors influencing time to site activation (days) for 150 site initiationsa
Median (range) | Univariable p-value* Multivariable p-value** | |
|---|---|---|
Overall (n = 150) | 234 (74, 657) | |
Phase | ||
1 (n = 17) | 160 (114, 269) | < 0.001* |
2 (n = 27) | 192 (74, 657) | 0.013** |
3 (n = 98) | 250 (106, 617) | |
4 (n = 8) | 289 (85, 350) | |
Disease area of trial | ||
Nephrology (n = 54) | 230 (74, 617) | 0.7* |
Oncology (n = 40) | 249 (94, 346) | 0.026** |
Endocrinology (n = 24) | 244 (106, 372) | |
Neurology (n = 22) | 294 (82, 657) | |
Paediatrics (n = 10) | 226 (138, 519) | |
Country | ||
Australia (n = 126) | 236 (74, 657) | 0.039* |
South Korea (n = 10) | 230 (211, 312) | NA** |
Hong Kong SAR (n = 5) | 395 (262, 426) | |
Taiwan (n = 5) | 174 (154, 252) | |
New Zealand (n = 4) | 184 (177, 196) | |
Trial site ownership | ||
Government (n = 108) | 248 (74, 657) | 0.039* |
Private (n = 18) | 188 (114, 484) | 0.8** |
N/A (n = 24) | 230 (154, 426) | |
Mutual acceptance of other ethics committee approvals | ||
Yes (n = 79) | 230 (82, 601) | 0.031* |
No (n = 55) | 236 (74, 657) | 0.030** |
Unknown (n = 16) | 248 (94, 346) | |
Triage by low, medium, or high risk for ethics review | ||
Yes (n = 96) | 250 (74, 657) | > 0.9* |
No (n = 49) | 232 (138, 484) | 0.3** |
Unknown (n = 5) | 150 (94, 224) | |
Triage by low, medium, or high risk for governance review | ||
Yes (n = 111) | 236 (74, 617) | > 0.9* |
No (n = 31) | 224 (94, 657) | 0.8** |
Scope guidelines for the ethics review | ||
Yes (n = 116) | 233 (74, 657) | 0.2* |
No (n = 34) | 235 (144, 484) | 0.6** |
Unknown (n = 8) | 178 (114, 252) | |
Scope guidelines for the governance review | ||
Yes (n = 112) | 234 (74, 617) | > 0.9* |
No (n = 38) | 247 (114, 657) | > 0.3** |
COVID-19 pandemic | ||
Pre-pandemic (n = 114) | 248 (82, 657) | 0.007* |
During or after pandemic (n = 36) | 192 (74, 617) | 0.9** |