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Table 1 Characteristics of included protocols

From: Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

Characteristics of all protocols n = 133 2003–2008 (6 y) n = 47 2009–2014 (6 y) n = 86 p-value
Total Drug Non drug Drug Non drug
n (%) 27 (57.5) 20 (42.5) 43 (50) 43 (50)
Type of study
 Biomedical research 97 (72.9) 26 12 40 19 0.231
 Routine health care 31 (23.3) 1 6 3 21  
 Observational 5 (3.8) 0 2 0 3  
Sponsor
 Academic 69 (51.9) 6 15 6 42 0.276
 Industrial 64 (48.1) 21 5 37 1  
Population
 Only children 56 (42.1) 14 6 24 12 1.000
 Children and adults 77 (57.9) 13 14 19 31  
Sex
 Female 1 (0.8) 0 0 0 1 0.158
 Male 20 (15.0) 2 2 13 3  
 Both 112 (84.2) 25 18 30 39  
Methodology
 Randomized 50 (37.6) 20 7 20 3 0.000*
 Non-randomized 83 (62.4) 7 13 23 40  
Multicentric
 Yes 86 (64.6) 24 7 39 16 0.852
 No 47 (35.4) 3 13 4 27  
Sample size calculation
 Yes 66 (49.6) 17 8 21 20 0.589
 No 67 (50.4) 10 12 22 23  
Mention of necessary items for sample size calculation
 Yes 57 (42.9) 15 9 19 14 0.200
 No 76 (57.1) 12 11 24 29  
Interim analysis
 Yes 21 (15.8) 5 2 12 2 1.000
 No 112 (84.2) 22 18 31 41  
Subgroup analysis
 Yes 26 (19.5) 9 2 10 5 0.494
 No 107 (80.5) 18 18 33 38  
Intention to treat analysis
 Yes 54 (40.6) 19 7 19 9 0.016*
 No 79 (59.4) 8 13 24 34  
  1. The p value corresponds to the comparison of the two periods for each listed variable including both “drug” and “non drug” RCTs
  2. Data are n (%) of protocols; *p-value <0.05