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

Table 5 Data concerning the trial period of countries participating in the FAITH trial

	NL (N = 14)	CA (N = 11)	US (N = 29)	P-value
Time between ethics approval and start trial (days)	41 (10 - 139)	232 (98 - 423)	87 (45 - 255)	0.027^a
Enrolment period (days)	423 (381 - 509)	482 (267 - 663)	283 (142 - 360)	0.001^b
Inclusions	13 (7 - 27)	3 (0 - 5)	3 (1 - 6)	< 0.001^c
Registered patients	23 (12 - 36)	54 (3 - 75)	16 (5 - 27)	0.060
Patients missed for registration¹	35 (10 - 81)	Unknown	Unknown
Inclusions (n per month)	1.03 (0.43 - 2.21)	0.14 (0.00 - 0.28)	0.31 (0.09 - 0.62)	< 0.001^d
Total patients (n per month)	2.49 (1.60 - 3.64)	2.76 (0.60 - 8.75)	1.96 (1.11 - 3.75)	0.574
Proportion inclusions (% of total)	34.4 (23.8 - 62.6)	3.93 (0.00 - 13.2)	16.7 (2.50 - 31.3)	0.001^e
Proportion patients that were missed for registration of total¹ (%)	57.4 (32.2 - 65.2)	Unknown	Unknown
Completed follow-ups (%)	82.6 (80.0 - 84.6)	83.5 (72.7 - 95.2)	70.0 (60.0 - 88.1)	0.217
Follow-ups in window (%)	77.1 (71.0 - 82.2)	85.9 (81.0 - 95.0)	85.7 (70.0 - 100.0)	0.073

NL, the Netherlands; CA, Canada; US, United States.
Numbers in the headers represent the number of sites per country that data were available for.
Data are presented as median with P₂₅-P₇₅ given between brackets.
Statistics were calculated using the Kruskal-Wallis ANOVA.
¹ Data available for NL only.
Post-hoc pair wise comparisons were performed using a Mann-Whitney U-test: ^a Statistical significance was reached when comparing NL vs. CA (p = 0.010), other groups: not significant. ^b Statistical significance was reached when comparing NL vs. US (p < 0.001), other groups: not significant. ^c Statistical significance was reached when comparing NL vs. CA (p = 0.002) and NL vs. US (p < 0.001), CA vs. US: not significant. ^d Statistical significance was reached when comparing NL vs. CA (p = 0.001) and NL vs. US (p = 0.001), CA vs. US: not significant. ^e Statistical significance was reached when comparing NL vs. CA (p < 0.001) and NL vs. US (p = 0.009), CA vs. US: not significant.

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