Table 3.
Percentage of compliance of trial records according to WHO criteria by trial registry.
Registries (number of records) | |||||||||||||
International | National | Specialty | Pharma | ||||||||||
Criteria requested | ISCRTN (n = 100) | CT (n = 100) | ACTR (n = 50) | UK NRR (n = 50) | PDQ (n = 33) | STD (n = 33) | RT (n = 33) | R (n = 8) | GSK (n = 72) | N (n = 4) | CSR (n = 37) | Local (n = 90) | Total, % (95% CI) |
Unique trial number | 100 | 100 | 100 | 100 | 0 | 0 | 0 | 100 | 100 | 100 | 97.3 | 90 | 82.1 (78.9 to 85.1) |
Trial registration date | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 0 | 0 | 0 | 78.5 (75.0 to 81.7) |
Secondary Ids | 100 | 91 | 16 | 4 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 38.4 (34.5 to 42.4) |
Funding source(s) | 100 | 100 | 96 | 76 | 66.7 | 69.7 | 90 | 100 | 100 | 100 | 100 | 27.8 | 83.1 (79.9 to 86.0) |
Primary sponsor | 100 | 100 | 90 | 92 | 66.7 | 69.7 | 90.9 | 100 | 31.9 | 100 | 100 | 27.8 | 75.9 (72.3 to 79.2) |
Secondary sponsor(s) | 14 | 10 | 38 | 0 | 0 | 6.1 | 6.1 | 0 | 0 | 0 | 0 | 0 | 7.7 (5.7 to 10.1) |
Responsible contact person | 0 | 0 | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8.2 (6.1 to 10.7) |
Research contact person | 95 | 20 | 100 | 98 | 93.9 | 63.6 | 30.3 | 0 | 0 | 0 | 0 | 60 | 54.1 (50.1 to 58.1) |
Title of the study (brief title) | 98 | 18 | 66 | 0 | 0 | 60.6 | 0 | 0 | 0 | 0 | 0 | 12.2 | 29.5 (25.9 to 33.3) |
Official scientific title of the study | 83 | 95 | 100 | 94 | 97 | 69.7 | 84.9 | 100 | 100 | 0 | 89.2 | 82.2 | 89.3 (86.6 to 91.7) |
Research ethics review | 1 | 0 | 78 | 0 | 3 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 6.9 (5.0 to 9.2) |
Condition | 70 | 85 | 92 | 66 | 97 | 100 | 84.9 | 100 | 95.8 | 100 | 83.8 | 22.2 | 75.2 (71.6 to 78.6) |
Intervention(s) | 56 | 68 | 74 | 24 | 75.8 | 97 | 42.4 | 0 | 100 | 0 | 64.9 | 17.8 | 58.4 (54.3 to 62.3) |
Key inclusion and exclusion criteria | 23 | 97 | 100 | 44 | 18.2 | 87.9 | 0 | 100 | 97.2 | 50 | 64.9 | 28.9 | 58.5 (54.5 to 62.5) |
Study type | 43 | 74 | 98 | 58 | 9.1 | 97 | 33.3 | 0 | 94.4 | 0 | 64.9 | 45.6 | 61.3 (57.3 to 65.2) |
Anticipated trial start date | 8 | 65 | 100 | 100 | 0 | 39.4 | 3 | 0 | 100 | 0 | 64.9 | 0 | 46.4 (42.4 to 50.4) |
Target sample size | 40 | 83 | 100 | 24 | 72.7 | 100 | 39.4 | 0 | 80.6 | 0 | 64.9 | 0 | 55.2 (51.2 to 59.2) |
Recruitment status | 3 | 99 | 100 | 100 | 93.9 | 100 | 12.1 | 100 | 0 | 0 | 54.1 | 7.8 | 50.0 (46.0 to 54.0) |
Primary outcome | 7 | 48 | 100 | 34 | 0 | 100 | 18.2 | 0 | 83.3 | 0 | 64.9 | 2.2 | 40.5 (36.6 to 44.5) |
Key secondary outcomes | 6 | 10 | 58 | 6 | 6.1 | 54.6 | 3 | 0 | 61.1 | 0 | 48.7 | 1.1 | 21.6 (18.4 to 25.1) |
Note: In CT, PDQ and STD 'Funding source(s)' and 'Primary sponsor' are not distinct. By default contact person without specification has been refereed to Research contact person.
Abbreviation: ISRCTN, Current Controlled Trials; CT, ClinicalTrials.gov; ACTR, Australian Clinical Trials Registry; UK NRR, UK National Research Register; PDQ, US National Cancer Institute; STD, Stroke Trials Directory; RT, Rehabilitation Trials; R, Roche; GSK, GlaxoSmithKline; N, Novartis; CSR, ClinicalStudyResults.