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Table 3 Registration, timeliness of registration, primary outcome concordance, and study results across clinical trials published in 10 high-impact US medical specialty society journals, stratified by trial characteristics

From: Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

  Total (column %) Registration Timeliness of registrationc, d Primary outcome Comparisong, h Primary outcome Resultsi
Unregistered (%)b RR (95% CI); chi-squared p value Retrospective (%)e RR (95% CI); chi-squared p value Retrospective after initial primary outcome ascertainment (%) e, f RR (95% CI); chi-squared p value Non-discordant (%)e RR (95% CI); chi-squared p value Favorable (%)j RR (95% CI); chi-squared p value
Total 486 (100) 47 (9.7)   99 (22.6)   67 (15.3)   249 (56.7)   282 (66.4)  
Drug/device/ biological
 Yes 392 (80.7) 31 (7.9) 0.46 (0.27–0.81); 0.0073 65 (18.0) 0.42 (0.30–0.58); <  0.001 42 (11.6) 0.37 (0.24–0.57); <  0.001 216 (59.8) 1.36 (1.05–1.77); 0.009 218 (64.7) 0.89 (0.77–1.03); 0.16
 No 94 (19.3) 16 (17.0) 34 (43.6) 25 (32.1) 33 (42.3) 64 (72.7)
Fundinga
 Industry 216 (44.4) 11 (5.1) 0.38 (0.20–0.73); 0.0023 25 (12.2) 0.39 (0.26–0.58); < 0.001 18 (8.8) 0.41 (0.25–0.68); < 0.001 131 (63.9) 1.22 (1.04–1.42); 0.014 117 (65.7) 0.98 (0.86–1.13); 0.82
 Non-industry 270 (55.6) 36 (13.3) 74 (31.6) 49 (20.9) 118 (50.4) 165 (66.8)
Location
  ≥ 1 US site 250 (51.4) 15 (6.0) 0.44 (0.25–0.80); 0.0048 35 (14.9) 0.47 (0.33–0.68); < 0.001 23 (9.8) 0.44 (0.28–0.71); < 0.001 133 (56.6) 0.94 (0.80–1.10); 0.44 148 (65.8) 0.98 (0.86–1.12); 0.79
 Non-US 236 (48.6) 32 (13.5) 64 (31.4) 44 (21.6) 116 (56.9) 134 (67.0)
Randomized
 Yes 372 (76.5) 23 (6.2) 0.29 (0.17–0.50); < 0.001 79 (22.6) 1.02 (0.66–1.58); 0.91 56 (16.0) 1.30 (0.71–2.36); 0.39 195 (55.9) 0.85 (0.72–1.02); 0.10 231 (64.0) 0.80 (0.69–0.93); 0.01
 No 114 (23.5) 24 (21.1) 20 (22.2) 11 (12.2) 54 (60) 51 (79.7)
Enrollment
  ≥ 100 280 (57.6) 9 (3.2) 0.17 (0.09–0.35); < 0.001 58 (21.4) 0.88 (0.62–1.25); 0.49 43 (15.9) 1.10 (0.69–1.74); 0.69 162 (59.8) 1.06 (0.90–1.25); 0.47 161 (62.7) 0.87 (0.76–0.99); 0.046
  < 100 206 (42.4) 38 (18.5) 41 (24.4) 24 (14.3) 87 (51.8) 121 (72.0)
  1. aTrials receiving either full or partial industry support were designated as having received industry funding
  2. bPercentages are expressed as the fraction of total trials in each row
  3. cTrials registered > 30 days after enrollment start were considered to have been registered retrospectively. Note that ICMJE policy mandates registration prior to enrollment start
  4. dAmong 439 registered trials, we could not determine timeliness of registration for 2 (1 published in Gastroenterology and the other in Journal of Clinical Oncology), as enrollment start date was missing from registrations. We excluded these 2 trials from analyses of association pertaining to overall timeliness of registration and timelines of registration relative to initial primary outcome ascertainment
  5. ePercentages are expressed as the fraction of registered trials (total −kindly advise if my minus sign inclusion here is correct; please alter as need if not unregistered) in each row
  6. fDue to the nature of the primary outcome (i.e., median survival), we could not determine if retrospective registration occurred after initial primary outcome ascertainment in 8 cases: 1 in Blood; 1 in Hepatology; 2 in Journal of Allergy and Clinical Immunology; and 4 in Journal of Clinical Oncology. These trials were excluded from analyses of association pertaining to timeliness of registration relative to initial primary outcome ascertainment
  7. gRegistered and published primary outcomes were considered non-discordant if they did not explicitly differ in any of the following 3 domains: number of outcomes, outcome definition(s), or outcome time frame(s)
  8. h26 of 439 registered trials did not have a primary outcome designated in their publication and were, therefore, excluded from analyses of association pertaining to primary outcome comparison
  9. iPrimary outcome favorability could not be judged for 61 trials. These trials were excluded from analyses of association pertaining to primary outcome favorability
  10. jPercentages are expressed as the fraction of trials in each row for which primary outcome favorability could be judged (row totals not shown)
  11. Abbreviations: RR relative risk, CI confidence interval