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**

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 phase; disease area; country; trial site 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; and pre- or post-COVID in the regression model