Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

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

ISSN: 1745-6215