Table 2 Study classification, identification and results availability in the HPV vaccine industry study programmes and non-industry funded clinical studies
Study classification, identification and results availability | Industry HPV vaccine studies | Non-industry funded HPV vaccine studies | P valueh | ||||||
|---|---|---|---|---|---|---|---|---|---|
Total: N = 145 | GSK (Cervarix): N = 69 | Merck (Gardasil and Gardasil 9): N = 66 | Otherg: N = 10 | Total: N = 61 | Cervarix: N = 6 | Gardasil and Gardasil 9: N = 48 | Other: N = 7 | ||
Study classificationa | |||||||||
‘Definitely exists’ | 127 (88%) | 69 (100%) | 50 (76%) | 8 (80%) | 33 (54%) | 5 (83%) | 28 (58%) | 0 (0%) | < 0.0001 |
‘Probably exists’ | 18 (12%) | 0 (0%) | 16 (24%) | 2 (20%) | 28 (46%) | 1 (17%) | 20 (42%) | 7 (100%) | < 0.0001 |
Study identification (ID) | |||||||||
Uses study programme specificb ID | 125 (86%) | 66 (96%) | 49 (74%) | 10 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | < 0.0001 |
Uses manufacturer specificc ID | 98 (68%) | 68 (99%) | 30 (45%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | < 0.0001 |
Uses both study programme and manufacturer specific IDs | 95 (66%) | 65 (94%) | 30 (45%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | < 0.0001 |
Uses national clinical study (NCT) ID | 132 (91%) | 64 (93%) | 58 (88%) | 10 (100%) | 44 (72%) | 6 (100%) | 33 (69%) | 5 (71%) | 0.0009 |
Uses study programme, manufacturer specific and NCT IDs | 91 (63%) | 61 (88%) | 30 (45%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | < 0.0001 |
Uses additional or other ID(s) | 42 (29%) | 26 (38%) | 16 (24%) | 0 (0%) | 51 (84%) | 5 (83%) | 40 (83%) | 6 (86%) | < 0.0001 |
Study results availability | |||||||||
Listed in a register or databased | 138 (95%) | 69 (100%) | 59 (89%) | 10 (100%) | 57 (93%) | 6 (100%) | 45 (94%) | 6 (86%) | 0.73 |
Listed on ClinicalTrials.gov | 132 (90%) | 64 (93%) | 58 (88%) | 10 (100%) | 44 (72%) | 6 (100%) | 33 (69%) | 5 (71%) | 0.0009 |
- Results posted on ClinicalTrials.gov | 65 of 132 (44%) | 37 of 64 (58%) | 28 of 58 (48%) | 0 of 10 (0%) | 6 of 44 (14%) | 0 of 6 (0%) | 6 of 33 (18%) | 0 of 5 (0%) | 0.0002 |
- Results posted on ClinicalTrials.gov for completed studies | 65 of 110 (58%) | 37 of 57 (65%) | 28 of 49 (57%) | 0 of 4 (0%) | 6 of 37 (16%) | 0 of 3 (0%) | 6 of 29 (21%) | 0 of 5 (0%) | < 0.0001 |
Published in a biomedical journale | 76 of 110 (69%) | 42 of 57 (74%) | 34 of 49 (69%) | 0 of 4 (0%) | 16 of 39 (41%) | 3 of 3 (100%) | 12 of 29 (41%) | 1 of 7 (14%) | 0.004 |
Probably not published in a biomedical journale,f | 34 of 110 (31%) | 15 of 57 (26%) | 15 of 49 (31%) | 4 of 4 (100%) | 23 of 39 (59%) | 0 of 3 (0%) | 17 of 29 (59%) | 6 of 7 (86%) | 0.004 |