TABLE 4.
Domain | Measure | All Trials (N = 1636) | Pediatric Trials (N = 207) | Adult Trials (N = 1429) | Pa |
---|---|---|---|---|---|
Trial design | Primary funding source, n (%) | <.001 | |||
Industry | 812 (49.6) | 61 (29.5) | 751 (52.6) | ||
Government | 100 (6.1) | 16 (7.7) | 84 (5.9) | ||
Nonprofit | 724 (44.2) | 130 (62.8) | 593 (41.5) | ||
Study phase, n (%) | <.001 | ||||
Phases 1, 2, 2/3 | 608 (37.2) | 41 (19.8) | 567 (39.7) | ||
Phases 3, 4 | 866 (52.9) | 128 (61.8) | 738 (51.6) | ||
Unknown phase | 162 (9.9) | 38 (18.4) | 124 (8.7) | ||
Comparator type, n (%) | .41 | ||||
Active agent | 770 (47.1) | 103 (49.8) | 666 (46.6) | ||
Placebo | 866 (52.9) | 104 (50.2) | 768 (53.4) | ||
Masking, n (%) | .18 | ||||
Double-blind | 1217 (74.4) | 144 (69.6) | 1073 (75.1) | ||
Single blind | 72 (4.4) | 9 (4.4) | 62 (4.3) | ||
No blinding | 347 (21.2) | 54 (26.1) | 293 (20.5) | ||
Inclusion of primary safety outcome, n (%) | 261 (16.0) | 20 (9.7) | 241 (16.9) | .008 | |
Scope, n (%) | .007 | ||||
Multicenter | 938 (57.3) | 102 (49.3) | 835 (58.5) | ||
Single center | 600 (36.7) | 96 (46.4) | 504 (35.3) | ||
Unknown | 98 (6.0) | 9 (4.4) | 89 (6.2) | ||
Anticipated sample size, median (IQR)b | 142 (50–390) | 220 (90–450) | 124 (50–380) | <.001 | |
Length of trial conduct, y, median (IQR)c | 1.7 (1.0–2.7) | 1.8 (1.0–2.7) | 1.7 (1.0–2.7) | .53 | |
Trial conduct | Registration before study start, N (%) | 659 (40.3) | 97 (46.9) | 562 (39.3) | .04 |
Registration before study completion, n (%)c | 1359 (95.4) | 170 (92.9) | 1189 (95.7) | .09 | |
Attainment of ≥75% anticipated study sample, n (%)d | 180 (90.0) | 34 (89.5) | 146 (90.1) | .90 | |
Provision of study results, n (%) | 120 (7.3) | 16 (7.7) | 104 (7.3) | .82 | |
Results reporting | Outcomed,e | .62 | |||
Positive | 121 (67.2) | 22 (71.0) | 99 (66.4) | ||
Negative | 59 (32.8) | 9 (29.0) | 50 (33.6) |
IQR, interquartile range.
P value based on χ2 for categorical variables, Student t test for mean values, and Kruskal-Wallis test for median values.
Based on 1622 trials with enrollment data.
Based on 1425 trials with available completion dates.
Based on 200 trials with publications.
Five publications included results pooled from 2 studies; 15 trials designated as neither positive or negative.