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

CharacteristicsAll
(n=6679)
Industry studies
(n=4176)
Non-industry studies
(n=2503)
Primary sponsor
 Industry2713 (40.6%)
 NIH286 (4.3%)
 US Fed15 (0.2%)
 Other3665 (54.9%)
Industry involved either as a primary sponsor or a collaborator4176 (62.5%)
Number of postmarketing studies per drug
 Minimum/maximum3/530
 Median (Q1–Q3)55 (30–119)
 Mean (SD)96.8 (110.3)
Population size per drug
 Minimum/maximum67/1.05E6
 Median (Q1–Q3)15 418 (4932–37 523)
 Mean (SD)62 748 (166 644)
Therapeutic class according to the ATC
 Alimentary tract and metabolism832 (12.5%)570 (68.5%)262 (31.5%)
 Anti-infectives for systemic use828 (12.4%)504 (60.9%)324 (39.1%)
 Antineoplastic and immunomodulating agents3040 (45.5%)1818 (59.8%)1222 (40.2%)
 Blood and blood forming organs446 (6.7%)277 (62.1%)169 (37.9%)
 Nervous system485 (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 indication2441 (36.5%)1310 (53.6%)1131 (46.4%)
 Originally approved indication3993 (59.8%)2742 (68.7%)1251 (31.3%)
 Both the originally approved indication and another indication245 (3.7%)124 (50.6%)121 (49.3%)
Study type
 Observational707 (10.6%)468 (66.2%)239 (33.8%)
 Interventional5972 (89.4%)3708 (62.1%)2264 (37.9%)
Randomisation
 Missing data245214281024
 Yes3067 (72.6%)1979 (64.5%)1088 (35.5%)
 No1160 (27.4%)769 (66.3%)391 (33.7%)
Study phase
 Missing data1052554498
 034 (0.6%)13 (38.2%)21 (61.8%)
 I933 (16.6%)651 (69.8%)282 (30.2%)
 I/II423 (7.5%)245 (58.0%)178 (42.0%)
 II1837 (32.6%)1047 (57.0%)790 (43.0%)
 II/III109 (1.9%)52 (47.7%)57 (52.3%)
 III1246 (22.1%)1018 (81.7%)228 (18.3%)
 IV1045 (18.6%)596 (57.0%)449 (43.0%)
Centres
 Missing data50342875
 Minimum/maximum1/16161/16161/922
 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 data50142774
 Minimum/maximum1/461/461/15
 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 data1495
 Minimum/maximum1/904 5851/904 5851/61 050
 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 recruiting319 (4.8%)136 (42.6%)183 (57.4%)
 Recruiting1895 (28.4%)886 (46.8%)1009 (53.2%)
 Active, not recruiting1013 (15.2%)627 (61.9%)386 (38.1%)
 Enrolling by invitation64 (1.0%)42 (65.6%)22 (34.4%)
 Completed2901 (43.4%)2147 (74.0%)754 (26.0%)
 Terminated487 (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.