Table 1.
Baseline characteristics of study protocols from randomised controlled trials that were ethically approved in 2012 or 2016
| 2012 (n=103) |
2016 (n=108) |
Total (n=211) |
|
|---|---|---|---|
| Target sample size, median (IQR) | 180 (90-430) | 222 (93-391) | 200 (90-400) |
| Sponsorship | |||
| Industry-sponsored | 49 (47.6%) | 62 (57.4%) | 111 (52.6%) |
| Non-industry-sponsored | 54 (52.4%) | 46 (42.6%) | 100 (47.4%) |
| Number of trial arms | |||
| 2 arms | 76 (73.8%) | 82 (75.9) | 158 (74.9%) |
| 3 arms | 17 (16.5%) | 16 (14.8%) | 33 (15.6%) |
| 4 arms | 7 (6.8%) | 7 (6.5%) | 14 (6.6%) |
| >4 arms | 3 (2.9%) | 3 (2.8%) | 6 (2.8%) |
| Centres | |||
| Single-centre | 25 (24.3%) | 22 (20.4%) | 47 (22.3%) |
| Multicentre | 77 (74.8%) | 84 (77.8%) | 161 (76.3%) |
| Unclear | 1 (1.0%) | 2 (1.9%) | 3 (1.4%) |
| Countries | |||
| National | 61 (59.2%) | 45 (41.7%) | 106 (50.2%) |
| International | 42 (40.8%) | 63 (58.3%) | 105 (48.8%) |
| Hypothesis | |||
| Superiority | 84 (81.6%) | 95 (88.0%) | 179 (84.8%) |
| Non-inferiority | 11 (10.7%) | 8 (7.4%) | 19 (9.0%) |
| Superiority and non-inferiority | 2 (1.9%) | 0 (0.0%) | 2 (1.0%) |
| Unclear/not labelled in this regard | 6 (5.8%) | 5 (4.6%) | 11 (5.2%) |
Abbreviations: IQR interquartile range