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Table 3 Analysis of factors associated with the implementation duration using multivariable regression: 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, multivariable mixed linear model with a random intercept for year of grant ( n = 139)
 Variable Coefficient (95 % CI) p -value
 Intercept 22.3 (18.5;26.1)  
 Funding mechanism (ref. = Government)   <0.001
 External -7.7 (-11.9;-3.5) <0.001
 Internal -5.3 (-9.8;-0.8) 0.02
 Number of centers a -0.1 (-0.2;0.02) 0.07
 Type of study (ref = Observational)   0.003
 Interventional involving drug therapy 6.0 (0.7;11.3) 0.03
 Interventional without drug therapy 3.5 (-0.3;7.3) 0.06
b) Studies involving drug therapy, using multivariable linear regression ( n = 35)
 Variable Coefficient (95 % CI) p -value
 Intercept 14.9 (6.9;22.9)  
 Funding mechanism (ref. = Government)   0.08
 External -6.7 (-13.2;-0.2) 0.05
 Internal -2.9 (-9.8;4.0) 0.41
 Study population (ref. = Mixed population)   0.01
 Pediatric population 7.8 (1.1;14.5)  
 Placebo-controlled study 6.6 (0.9;12.3) 0.01
 Age-appropriate formulation (ref. = Appropriate)   0.05
 Intermediate at least for one drug of the study -3.6 (-13.0;5.8) 0.44
 Inappropriate at least for one drug of the study 6.9 (-0.2;14.0) 0.06
  1. aFor an increase of 1 centre
  2. For all multivariable regression models, P < 0.20 was used for the variable entry criteria. Then, a stepwise selection procedure was applied. Because the statistical analyses were essentially exploratory, factors associated with the considered outcome with P < 0.10 were kept in the final model. Variables dropped at earlier stages were re-evaluated for inclusion in the final model
  3. Values shown are coefficient, 95 % confidence interval (95 % CI). Individual p-value for each category of the variables are shown (in italics), as well as the global p-value of the variable (in bold)