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Table 2 Summary of the study designs of the clinical trials

From: Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region

Items Definition All cases completed Not all cases completed p value
n = 95 n = 47
   n (%) n (%)  
Rare disease Yes 27 (28.4) 13 (27.7) 0.92
Phase 2 28 (29.5) 18 (38.3) 0.87
2/3 2 (2.1) 0 (0)  
3 50 (52.6) 22 (46.8)  
Other 15 (15.8) 7 (14.9)  
Randomized Yes 58 (61.1) 30 (63.8) 0.75
Double-blind Yes 42 (44.2) 19 (40.4) 0.67
Clinical trials that included newborns or infants and toddlers Yes 19 (20) 10 (21.7) 0.86
   Median, min–max Median, min–max  
Number of enrolled participants per age categories All age categories including over 18 years 111, 1–4176 42, 6–1177 0.02
Newborn 0, 0–16 0, 0–4 0.43
Infant and toddler 0, 0–1229 0, 0–110 0.67
Child 2, 0–978 0, 0–506 0.07
Adolescent 8, 0–448 1, 0–327 0.03
Number of countries in which the clinical trial was conducted   2, 1–10 4, 1–18 < 0.001
Year clinical trial started 2014 41 (43) 24 (51) 0.65
2015 32 (34) 10 (21)  
2016 16 (17) 10 (21)  
2017 6 (6.3) 3 (6.4)  
Trial period (days) Final date–start date + 1 616, 130–1570 723.5, 81–1524 0.18
  1. p values; chi-square test for categorical variables/Mann-Whitney U test for continuous variables