Table 1.
Baseline Characteristics of Included Randomized Controlled Trials
| Studies with preemptive press release | Studies without preemptive press release | |
|---|---|---|
| n = 172 | n = 816 | |
| Trial sample size (IQR) | 630 (331, 1474) | 582 (260, 1716) |
| Journal (n, %) | ||
| NEJM | 89 (51.7) | 373 (45.7) |
| JAMA | 10 (5.8) | 176 (21.6) |
| Lancet | 73 (42.4) | 267 (32.7) |
| Year of publication (n, %) | ||
| 2015 | 27 (15.7) | 161 (19.7) |
| 2016 | 35 (20.3) | 142 (17.4) |
| 2017 | 44 (25.6) | 153 (18.8) |
| 2018 | 32 (18.6) | 148 (18.1) |
| 2019 | 34 (19.8) | 212 (26.0) |
| Disease area (n, %) | ||
| Cardiovascular disease | 22 (12.8) | 144 (17.6) |
| Endocrinology | 7 (4.1) | 39 (4.8) |
| Infectious disease | 19 (11.0) | 135 (16.5) |
| Neurology | 15 (8.7) | 53 (6.5) |
| Oncology | 48 (27.9) | 131 (16.1) |
| Psychiatry | 2 (1.2) | 17 (2.1) |
| Respirology | 13 (7.6) | 60 (7.4) |
| Other | 46 (26.7) | 237 (29.0) |
| Funding source (n, %) | ||
| Pharma | 156 (90.7) | 326 (40.0) |
| Non-pharma | 11 (6.4) | 410 (50.2) |
| Combined | 5 (2.9) | 80 (9.8) |
| Blinding (n, %) | ||
| Double | 96 (55.8) | 402 (49.3) |
| Single | 3 (1.7) | 64 (7.8) |
| Unblinded (open label) | 73 (42.4) | 350 (42.9) |
| Comparator (n, %) | ||
| Placebo/sham | 88 (51.2) | 407 (49.9) |
| Active comparator | 77 (44.8) | 348 (42.6) |
| Other | 7 (4.1) | 61 (7.5) |
| Surrogate marker endpoint (n, %) | ||
| Yes | 97 (56.4) | 337 (41.3) |
| No | 75 (43.6) | 479 (58.7) |
| Primary endpoint result (n, %) | ||
| Negative | 3 (1.7) | 19 (2.3) |
| Neutral | 23 (13.4) | 290 (35.5) |
| Positive | 146 (84.9) | 507 (62.1) |
Abbreviations: IQR, interquartile range denotes the first and third quartile; JAMA, Journal of the American Medical Association; NEJM, New England Journal of Medicine