Table 1.
Characteristics of included trials
| Variables | No (%) | |
|---|---|---|
| Total cohort (31 818 trials) | Cohort with results due (7274 trials) | |
| Results available | 9876 (31.0) | 3601 (49.5) |
| Completion year: | ||
| 2004 | 4 (0.0) | 3 (0.0) |
| 2005 | 100 (0.3) | 72 (1.0) |
| 2006 | 475 (1.5) | 276 (3.8) |
| 2007 | 762 (2.4) | 444 (6.1) |
| 2008 | 1121 (3.5) | 658 (9.1) |
| 2009 | 1123 (3.5) | 654 (9.0) |
| 2010 | 1143 (3.6) | 699 (9.6) |
| 2011 | 1204 (3.8) | 731 (10.1) |
| 2012 | 1137 (3.6) | 713 (9.8) |
| 2013 | 1258 (4.0) | 737 (10.1) |
| 2014 | 1251 (3.9) | 803 (11.0) |
| 2015 | 1210 (3.8) | 782 (10.8) |
| 2016 | 1180 (3.7) | 702 (9.7) |
| 2017 | 1015 (3.2) | - |
| 2018 | 4 (0.0) | - |
| Missing | 18 831 (59.2) | - |
| Trial status: | ||
| All countries, ongoing | 12 947 (40.7) | - |
| All countries, complete or terminated | 11 531 (36.2) | 7274 (100.0) |
| Any countries, complete or terminated | 5754 (18.1) | - |
| Other (eg, suspended) | 519 (1.6) | - |
| Blank | 1067 (3.4) | - |
| Phase: | ||
| Discordant between countries | 398 (1.3) | 83 (1.1) |
| I | 1569 (4.9) | 23 (0.3) |
| II | 12 191 (38.3) | 3247 (44.6) |
| III | 10 282 (32.3) | 2340 (32.2) |
| IV | 7378 (23.2) | 1581 (21.7) |
| Sponsor class: | ||
| Non-commercial | 14 408 (45.3) | 2353 (32.4) |
| Commercial | 16 964 (53.3) | 4837 (66.5) |
| Mixed | 265 (0.8) | 57 (0.8) |
| Blank | 181 (0.6) | 27 (0.4) |
| Part of paediatric investigation plan | 1042 (3.3) | 107 (1.5) |
| Condition being studied is rare disease: | ||
| No | 27 496 (86.4) | 6584 (90.5) |
| Yes | 3723 (11.7) | 584 (8.0) |
| Discordant between countries | 382 (1.2) | 45 (0.6) |
| Data not available | 217 (0.7) | 61 (0.8) |
| Bioequivalence study: | ||
| No | 31 738 (99.8) | 7264 (99.9) |
| Yes | 66 (0.2) | 9 (0.1) |
| Discordant between countries | 14 (0.0) | 1 (0.0) |
| Participants are healthy volunteers: | ||
| No | 29 132 (91.6) | 6555 (90.1) |
| Yes | 2638 (8.3) | 708 (9.7) |
| Discordant between countries | 48 (0.2) | 11 (0.2) |
| Total No of trials registered for trial’s sponsor: | ||
| First quarter (1-10) | 8146 (25.6) | 1907 (26.2) |
| Second quarter (11-53) | 7971 (25.1) | 1677 (23.1) |
| Third quarter (54-244) | 7953 (25.0) | 1547 (21.3) |
| Fourth quarter (274-1260) | 7748 (24.4) | 2143 (29.5) |
| No sponsor name given | 145 (0.5) | 18 (0.3) |
| Unclear sponsor name given | 227 (0.7) | 66 (0.9) |
| All sites terminated | 2155 (6.8) | 1062 (14.6) |
| No of countries: | ||
| 1 | 20 476 (64.4) | 4536 (62.4) |
| 2 | 2611 (8.2) | 941 (12.9) |
| ≥3 | 8731 (27.4) | 1797 (24.7) |
| Trial has multiple sponsors | 982 (3.1) | 145 (2.0) |