Table 1.
Basic characteristics of trials adopting routine on-site monitoring and hybrid monitoring.
| Category | Routine on-site monitoring (n=91) | Hybrid monitoring (n=110) | P value | |
| Trial phase , n (%) | ||||
|
|
Phase I | 18 (19.8) | 27 (24.5) | .14 |
|
|
Phase II | 24 (26.4) | 38 (34.5) |
|
|
|
Phase III | 49 (53.8) | 45 (40.9) |
|
| Blinding method , n (%) | ||||
|
|
Yes | 25 (27.5) | 18 (16.4) | .06 |
|
|
No | 66 (72.5) | 92 (83.6) |
|
| Medication category , n (%) | ||||
|
|
Biologics | 66 (72.5) | 78 (70.9) | .80 |
|
|
Chemicals | 25 (27.5) | 32 (29.1) |
|
| Administration , n (%) | ||||
|
|
Single medication | 43 (47.3) | 53 (48.2) | .90 |
|
|
Combination | 48 (52.7) | 57 (51.8) |
|
| Nature of the trial , n (%) | ||||
|
|
Local | 61 (67) | 81 (73.6) | .51 |
|
|
Multinational | 30 (33) | 29 (26.4) |
|
| Trial stage , n (%) | ||||
|
|
Enrollment period | 45 (49.5) | 67 (60.9) | .10 |
|
|
Follow-up period | 46 (50.5) | 43 (29.1) |
|
| Number of patients, mean (SD) | 9.13 (12.739) | 9.87 (11.669) | .44 | |