Skip to main content

Advertisement

Table 1 Characteristics of the random sample of 300 phase III or IV trials with at least one serious adverse event (SAE) posted at ClinicalTrials.gov for which publications were sought

From: Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles

Characteristic Sample of trials with at least one SAE posted at ClinicalTrials.gov Sample of trials with corresponding published article
(n = 300) (n = 202)
Study phase
 III 234 (78) 168 (83)
 IV 66 (22) 34 (17)
Study design
 Parallel groups 287 (95) 197 (97)
 Cross-over 9 (3) 5 (3)
 Factorial 2 (1) 0 (0)
 Other 2 (1) 0 (0)
No. of intervention groups
 Two 233 (78) 169 (88)
 Three 60 (20) 33 (12)
 Other 7 (2) 0 (0)
Primary funding source
 Industry 264 (88) 178 (88)
 US National Institutes of Health 8 (3) 7 (3)
 US federal funding 1 (0) 1 (1)
 Other 27 (9) 16 (8)
Medical condition
 Endocrinology 41 (14) 32 (16)
 Infectious diseases 38 (13) 22 (11)
 Cardiology 31 (10) 18 (9)
 Neurology 29 (10) 23 (11)
 Oncology 29 (10) 23 (11)
 Rheumatology 22 (7) 13 (7)
 Pulmonary 20 (6) 15 (7)
 Other 90 (30) 56 (28)
Study location
 At least one site in the United States 205 (68) 140 (69)
 No site in the United States 95 (32) 62 (31)
Type of journal
 Specialty   165 (82)
 General   37 (18)
ClinicalTrials.gov NCT reported in article
 Yes   162 (80)
 No   40 (20)
  1. Data are no. (%)