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] | ||