Table 2.
Description of characteristics for controlled studies and uncontrolled studies.
| Variable | Controlled studies | Uncontrolled studies | P-valueb,c | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall N = 1212a (col %) | Analytical variable, N = 58a | Recruitment only N = 785a | No mention N = 369a | P-valueb | Overall, N = 204 (col %) | Analytical variable N = 20a | Recruitment only N = 43a | No mention N = 141a | P-valueb | ||
| Study type (n%) | - | 0.01 | - | ||||||||
| Interventional | 1212 | 58 (4.8) | 785 (65) | 369 (30) | 52 (25) | 4 (7.7) | 19 (37) | 29 (56) | |||
| Observational/Patient Registry | 152 (75) | 16 (11) | 24 (16) | 112 (74) | |||||||
| Overall status (n%) | 0.02 | 0.9 | 0.07 | ||||||||
| Active, not recruiting | 149 (12) | 9 (6) | 107 (72) | 33 (22) | 21 (10) | 2 (9.5) | 5 (24) | 14 (67) | |||
| Completed | 481 (40) | 19 (4) | 291 (60) | 171 (36) | 81 (40) | 9 (11) | 16 (20) | 56 (69) | |||
| Not yet recruiting | 95 (8) | 4 (4.2) | 66 (69) | 25 (26) | 9 (4) | 1 (11) | 2 (22) | 6 (67) | |||
| Recruiting/Enrolling by invitation | 318 (26) | 15 (4.7) | 221 (69) | 82 (26) | 51 (25) | 4 (7.8) | 13 (25) | 34 (67) | |||
| Unknown status/Suspended | 169 (14) | 11 (6.5) | 100 (59) | 58 (34) | 42 (21) | 4 (9.5) | 7 (17) | 31 (74) | |||
| Enrolment (n%) | 0.009 | 0.03 | <0.001 | ||||||||
| ≤100d | 879 (73) | 32 (3.6) | 573 (65) | 274 (31) | 116 (56) | 12 (10) | 32 (27) | 72 (63) | |||
| >100 | 333 (27) | 26 (7.8) | 212 (64) | 95 (29) | 88 (43) | 8 (9.1) | 11 (12) | 69 (78) | |||
| HPV mention (n%) | 222 (18) | 13 (5.9) | 160 (72) | 49 (22) | 0.01 | 43 (21) | 3 (7.0) | 8 (19) | 32 (74) | 0.7 | 0.40 |
| Phase (n%) | <0.001 | 0.05 | <0.001 | ||||||||
| Early Phase 1/Phase1 | 159 (13) | 6 (3.8) | 125 (79) | 28 (18) | 4 (2) | 0 (0) | 3 (75) | 1 (25) | |||
| Phase 1/Phase 2 | 85 (7) | 4 (4.7) | 61 (72) | 20 (24) | 2 (1) | 0 (0) | 1 (50) | 1 (50) | |||
| Phase 2/Phase 3 | 717 (59) | 33 (4.6) | 500 (70) | 184 (26) | 15 (7) | 0 (0) | 9 (60) | 6 (40) | |||
| Phase 4 | 16 (1) | 0 (0) | 12 (75) | 4 (25) | |||||||
| Not Applicabled | 235 (19) | 15 (6.4) | 87 (37) | 133 (57) | 183 (90) | 20 (11) | 30 (16) | 133 (73) | |||
The arms’ description was investigated within the dataset design groups. If at least one arm was defined as “Experimental”, “Active Comparator”, “Placebo Comparator”, “Sham Comparator” the study was classified as controlled, otherwise it was classified as uncontrolled (“No intervention”, “Other”).
an (%).
bPearson’s Chi-squared test or Fisher’s test.
cP-value from a Pearson’s Chi-squared test or Fisher’s test for controlled versus uncontrolled studies.
dmissing values included.