Table 2.
Summary of the characteristics of trials analyzed.
| Trial characteristic | Commercially sponsored | Noncommercially sponsored | P value |
|---|---|---|---|
| Number of trials, n (%) | 34 (63) | 20 (37) | |
| Sample size, median (IQR) | 342 (413) | 235 (337) | .17 |
| Total number of events, median (IQR) | 20 (34.25) | 14 (23) | .36 |
| Proportion of multicenter trials, n (%) | 25 (73.5) | 12 (60) | .21 |
| Retrospective registration of trial, n (%) | 7 (20.6) | 13 (65) | .007a |
| Superiority design, n (%) | 30 (88.2) | 18 (90) | .79 |
| Equivalence design, n (%) | 0 (0) | 2 (10) | .07 |
| Noninferiority design, n (%) | 4 (11.8) | 1 (5) | .38 |
| Intention-to-treat analysis, n (%) | 25 (73.5) | 6 (30) | .0006a |
| Use of composite primary outcome, n (%) | 20 (58.8) | 18 (90) | .048a |
| Estimated treatment effect, median (IQR) | 0.34 (0.44) | 0.18 (0.425) | .72 |
| Power, median (IQR) | 0.8 (0.08) | 0.8 (0.003) | .72 |
| Number of screened patients, median (IQR) | 372 (523) | 301 (334) | .20 |
| Percentage of screened patients included in sample size, median (IQR) | 97.6 (17.1) | 93.6 (20.9) | .26 |
| Sample size lost to follow-up, median (IQR) | 6.5 (9) | 2.5 (7.5) | .11 |
| Duration of follow-up, median (IQR)(days) | 60 (168) | 16 (23) | .07 |
| Favorable outcomes | 10/32 (31.2%) | 7/21 (33%) | .87 |
| Discrepancy in the primary outcome between the published manuscript and the registered protocol | 6/12 (50%) | 13/16 (81.2%) | .08 |
| Number of trials evaluated for spin | 22/33 (66.7%) | 14/21 (66.7%) | 1 |
| Spin present | 15/21 (71.4%) | 9/14 (64.3%) | .66 |
Characteristics of commercially and noncommercially sponsored trials were compared using the Mann–Whitney U-test for continuous variables and the Pearson chi-squared test for categorical variables or the Fisher’s exact test where appropriate.
a
Significant P < .05.