Trial characteristics | Total | Period 1 (1996–2001) | Period 2 (2002–2010) | Period 3 (2011–2016) | ||||
---|---|---|---|---|---|---|---|---|
Year of publication | 52 | - | 5 | (10%) | 27 | (52%) | 20 | (38%) |
Number of study arms | ||||||||
Two | 46 | (88%) | 3 | (60%) | 24 | (89%) | 19 | (95%) |
Three | 4 | (8%) | 1 | (20%) | 2 | (7%) | 1 | (5%) |
Four | 2 | (4%) | 1 | (20%) | 1 | (4%) | 0 | (0%) |
Blinding | ||||||||
Open-label | 29 | (56%) | 1 | (20%) | 17 | (63%) | 11 | (55%) |
Double-blind | 23 | (44%) | 4 | (80%) | 10 | (37%) | 9 | (45%) |
Region where the trial was conducted | ||||||||
Europe | 3 | (6%) | 1 | (20%) | 1 | (4%) | 1 | (5%) |
North America | 3 | (6%) | 2 | (40%) | 0 | (0%) | 1 | (5%) |
More than two regionsa | 44 | (85%) | 2 | (40%) | 24 | (89%) | 18 | (90%) |
Africa | 6 | 0 | 4 | 2 | ||||
Europe | 35 | 1 | 18 | 16 | ||||
Asia | 11 | 0 | 5 | 6 | ||||
North America | 39 | 2 | 19 | 18 | ||||
South America | 16 | 0 | 11 | 5 | ||||
Oceania | 19 | 1 | 7 | 11 | ||||
Not reported | 2 | (4%) | 0 | (0%) | 2 | (7%) | 0 | (0%) |
Number of sites | ||||||||
Median | 79.5 | 43 | 78 | 84.5 | ||||
Min | 19 | 28 | 48 | 19 | ||||
Max | 234 | 81 | 171 | 234 | ||||
Not reported | 8 | 0 | 6 | 2 | ||||
Number of patients | ||||||||
Median | 656.5 | 562 | 604 | 687 | ||||
Min | 92 | 297 | 186 | 92 | ||||
Max | 2463 | 2463 | 1506 | 1814 | ||||
Inclusion criteria of age | ||||||||
Adult | 36 | (69%) | 1 | (20%) | 17 | (63%) | 18 | (90%) |
Mixed (adults and children) | 10 | (19%) | 2 | (40%) | 8 | (30%) | 0 | (0%) |
Not reported | 6 | (12%) | 2 | (40%) | 2 | (7%) | 2 | (10%) |
Funding | ||||||||
Academic | 5 | (10%) | 2 | (40%) | 2 | (7%) | 1 | (5%) |
Industry | 44 | (85%) | 3 | (60%) | 22 | (81%) | 19 | (95%) |
Both | 1 | (2%) | 0 | (0%) | 1 | (4%) | 0 | (0%) |
Not reported | 2 | (4%) | 0 | (0%) | 2 | (7%) | 0 | (0%) |