Table 2.
Characteristics of industry and non-industry postmarketing studies registered at ClinicalTrials.gov before 24 September 2014 for the 69 novel drugs in the study sample
| Characteristics | All (n=6679) |
Industry studies (n=4176) |
Non-industry studies (n=2503) |
| Primary sponsor | |||
| Industry | 2713 (40.6%) | ||
| NIH | 286 (4.3%) | ||
| US Fed | 15 (0.2%) | ||
| Other | 3665 (54.9%) | ||
| Industry involved either as a primary sponsor or a collaborator | 4176 (62.5%) | ||
| Number of postmarketing studies per drug | |||
| Minimum/maximum | 3/530 | ||
| Median (Q1–Q3) | 55 (30–119) | ||
| Mean (SD) | 96.8 (110.3) | ||
| Population size per drug | |||
| Minimum/maximum | 67/1.05E6 | ||
| Median (Q1–Q3) | 15 418 (4932–37 523) | ||
| Mean (SD) | 62 748 (166 644) | ||
| Therapeutic class according to the ATC | |||
| Alimentary tract and metabolism | 832 (12.5%) | 570 (68.5%) | 262 (31.5%) |
| Anti-infectives for systemic use | 828 (12.4%) | 504 (60.9%) | 324 (39.1%) |
| Antineoplastic and immunomodulating agents | 3040 (45.5%) | 1818 (59.8%) | 1222 (40.2%) |
| Blood and blood forming organs | 446 (6.7%) | 277 (62.1%) | 169 (37.9%) |
| Nervous system | 485 (7.3%) | 304 (62.7%) | 181 (37.3%) |
| Other* | 1048 (15.7%) | 703 (67.1%) | 345 (32.9%) |
| Study design with respect to primary label | |||
| Another indication than the originally approved indication | 2441 (36.5%) | 1310 (53.6%) | 1131 (46.4%) |
| Originally approved indication | 3993 (59.8%) | 2742 (68.7%) | 1251 (31.3%) |
| Both the originally approved indication and another indication | 245 (3.7%) | 124 (50.6%) | 121 (49.3%) |
| Study type | |||
| Observational | 707 (10.6%) | 468 (66.2%) | 239 (33.8%) |
| Interventional | 5972 (89.4%) | 3708 (62.1%) | 2264 (37.9%) |
| Randomisation | |||
| Missing data | 2452 | 1428 | 1024 |
| Yes | 3067 (72.6%) | 1979 (64.5%) | 1088 (35.5%) |
| No | 1160 (27.4%) | 769 (66.3%) | 391 (33.7%) |
| Study phase | |||
| Missing data | 1052 | 554 | 498 |
| 0 | 34 (0.6%) | 13 (38.2%) | 21 (61.8%) |
| I | 933 (16.6%) | 651 (69.8%) | 282 (30.2%) |
| I/II | 423 (7.5%) | 245 (58.0%) | 178 (42.0%) |
| II | 1837 (32.6%) | 1047 (57.0%) | 790 (43.0%) |
| II/III | 109 (1.9%) | 52 (47.7%) | 57 (52.3%) |
| III | 1246 (22.1%) | 1018 (81.7%) | 228 (18.3%) |
| IV | 1045 (18.6%) | 596 (57.0%) | 449 (43.0%) |
| Centres | |||
| Missing data | 503 | 428 | 75 |
| Minimum/maximum | 1/1616 | 1/1616 | 1/922 |
| Median (Q1–Q3) | 2 (1–12) | 4 (1–23) | 1 (1–2) |
| Mean (SD) | 19.9 (62.1) | 26.4 (70.5) | 9.8 (44.7) |
| Countries | |||
| Missing data | 501 | 427 | 74 |
| Minimum/maximum | 1/46 | 1/46 | 1/15 |
| Median (Q1–Q3) | 1 (1–1) | 1 (1–2) | 1 (1–1) |
| Mean (SD) | 2.6 (4.7) | 3.6 (5.8) | 1.1 (0.7) |
| Planned enrolment | |||
| Missing data | 14 | 9 | 5 |
| Minimum/maximum | 1/904 585 | 1/904 585 | 1/61 050 |
| Median (Q1–Q3) | 60 (28–183) | 72 (30–248) | 48 24–100 |
| Mean (SD) | 649.6 (12 812.2) | 943.8(16 167.1) | 158.9 (1274.7) |
| Status at the time of data exportation | |||
| Not yet recruiting | 319 (4.8%) | 136 (42.6%) | 183 (57.4%) |
| Recruiting | 1895 (28.4%) | 886 (46.8%) | 1009 (53.2%) |
| Active, not recruiting | 1013 (15.2%) | 627 (61.9%) | 386 (38.1%) |
| Enrolling by invitation | 64 (1.0%) | 42 (65.6%) | 22 (34.4%) |
| Completed | 2901 (43.4%) | 2147 (74.0%) | 754 (26.0%) |
| Terminated | 487 (7.3%) | 338 (69.4%) | 149 (30.6%) |
*Includes cardiovascular system, dermatological, genitourinary system and sex hormones, musculoskeletal system, sensory organs, systemic hormonal preparations, excluding sex hormones, and other.
ATC, anatomical therapeutic chemical; NIH, US National Institutes of Health.