Table 3.
Data concerning the process of obtaining ethics/IRB approval of countries participating in the FAITH trial
| NL (N = 14) |
CA (N = 11) |
US (N = 19) |
P-value | |
|---|---|---|---|---|
| Time necessary for ethics/IRB approval1 (days) | 104 (74-135) |
55 (27 - 77) |
53 (44 - 105) |
0.027+ a |
| Revision rounds1 | 1 (0.0 - 1.0) | 1 (0.8 - 1.0) | 1 (1.0 - 3.0) | 0.014+ b |
| Type of revisions requested: | ||||
| Wording of IC Form2 | 6 (42.9) | 5 (50.0) | 12 (66.7) | 0.382++ |
| Content of IC Form2 | 6 (42.9) | 5 (50.0) | 8 (44.4) | 0.938++ |
| In- or exclusion criteria2 | 0 (0.0) | 1 (10.0) | 1 (5.3) | 0.511++ |
| Wording of study protocol2 | 0 (0.0) | 1 (10.0) | 0 (0.0) | 0.185++ |
| Content of study protocol2 | 1 (7.1) | 2 (20.0) | 1 (5.3) | 0.406++ |
| Additional information in study protocol/procedures2 | 5 (35.7) | 3 (30.0) | 7 (36.8) | 0.932++ |
| Financial aspects - Request for extra information2 |
0 (0.0) | 1 (10.0) | 3 (15.8) | 0.303++ |
| Request additional documents2 | 2 (14.3) | 0 (0.0) | 3 (15.8) | 0.421++ |
NL, the Netherlands; CA, Canada; US, United States.
Numbers in the headers represent the number of sites per country for which data were available.
IC, informed consent form.
1 Data are presented as median with P25-P75 given between brackets. 2 Data are presented as number with percentages.
+ Kruskal-Wallis ANOVA, ++ Chi-squared test
Post-hoc pair wise comparisons were performed using the Mann-Whitney U-test: a Statistical significance was reached when comparing NL vs. CA (p = 0.025), and NL vs. US (p = 0.019), CA vs. US: not significant. b Statistical significance was reached when comparing NL vs. US (p = 0.007), other groups: not significant