Table 1 Characteristics of included protocols
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 | |