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%) |