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** |
NA not applicable because only one country (Australia) had data to enable multivariable analyses
*p-value from univariable comparison
**p-value from multivariable comparison that included disease area; phase; ownership status (N/A data removed from ownership status); scope guidelines by the ethics committee; mutual acceptance of other ethics committee findings; an ethics process that triaged applications as low, medium, or high risk; the use of scope guidelines by the governance body; a governance approval process that triaged applications as low, medium or high risk; and pre- or post-COVID in the regression model
aIncluding 19 initiation times imputed as ‘site activation’ as the date the first patient was recruited