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Table 2 Bivariate analyses of factors associated with the duration of the study implementation: a- all included studies (n = 139), b- restricted to studies involving drug therapy (n = 35)

From: Academic pediatric clinical research: factors associated with study implementation duration

  a-All studies (n = 139) b-Studies involving drug therapy (n = 35)
Characteristics Implementation duration in months, or correlation coefficient p-value Implementation duration in months, or correlation coefficient p-value
Grant characteristics     
Funding mechanism   0.002   0.007
Government 22.6 (11.3)   25.2 [21.2;31.7]  
External 15.3 (9.5)   13.7 [11.9;17.3]  
Internal 18.9 (8.9)   18.0 [15.9;31.9]  
Year of grant   0.01   0.13
2002 14.9 [11.5;19.9]   17.8 [16.0;32.9]  
2003 19.1 [13.1;30.5]   22.8 [14.8;28.0]  
2004 17.4 [12.5;22.4]   15.9 [15.2;17.4]  
2005 12.3 [10.8;16.6]   15.9 [12.9;17.1]  
2006 20.8 [14.5;27.3]   22.1 [14.5;27.0]  
2007 20.9 [15.5;30.0]   21.7 [14.0;29.4]  
2008 23.7 [15.2;31.0]   36.5 [34.2;38.7]  
Methodological characteristics     
Coordinator center   0.85   0.46
General hospital 19.7 (10.9)   17.2 [13.7;24.4]  
Pediatric hospital 20.0 (10.7)   19.4 [15.1;29.6]  
Number of centers ρ = -0.09 0.32 ρ = 0.09 0.62
Type of study   0.03   -
Interventional involving drug therapy 17.8 [13.9;28.3]   -  
Interventional without drug therapy 20.4 [14.8;30.1]   -  
Observational 15.5 [11.0;21.3]   -  
International study   0.81   0.77
Yes 21.7 [13.8;22.8]   22.2 [19.7;25.1]  
No 16.5 [12.7;24.3]   17.2 [14.1;30.8]  
Rare disease   0.007   0.30
Yes 21.1 (12.0)   19.4 [13.9;30.4]  
No 16.8 (6.4)   16.6 [15.2;18.1]  
Chronic disease   0.65   0.31
Yes 19.6 (10.3)   19.7 [14.1;29.4]  
No 20.7 (12.3)   15.9 [13.3;17.4]  
Study population   0.34   0.05
Pediatric population 20.7 (10.7)   19.4 [15.9;29.4]  
Mixed population 18.9 (10.9)   13.9 [10.6;17.2]  
Length of participation ρ = 0.08 0.36 ρ = 0.12 0.49
Pharmaceutical characteristics     
Inclusion of children under 6 years old   -   0.24
Yes -   15.9 [13.4;18.7]  
No -   18.7 [14.2;29.9]  
Randomized study   -   0.04
Yes -   20.8 [15.4;30.8]  
No -   14.3 [11.9;17.4]  
Duration of treatment, days - - ρ = 0.04 0.81
Blinded investigator and/or blinded patient   -   0.06
Yes -   23.0 [15.9;31.3]  
No -   16.4 [12.3;21.1]  
Placebo-controlled study   -   0.01
Yes -   29.4 [17.4;31.9]  
No -   16.4 [12.3;19.9]  
At least a drug of the study not approved in pediatric population   -   0.33
Yes -   17.4 [14.2;27.8]  
No -   22.9 [16.3;28.6]  
Age-appropriate formulation   -   0.05
Appropriate -   16.7 [13.6;25.3]  
Intermediate at least for one drug of the study -   17.4 [17.1;18.7]  
Inappropriate at least for one drug of the study -   30.7 [24.6;32.8]  
Route of administration   -   0.37
Enterally at least for one drug of the study -   20.0 [14.8;30.4]  
Parenterally -   17.6 [13.5;21.9]  
  1. Values of the duration of the study implementation are reported as mean (Standard Deviation) or median [25th percentile;75th percentile]