pCRFs n = 16 | eCRFs n = 11 | All n = 27 | ||
---|---|---|---|---|
Design | Non-interventional studies | 1 (6%) | 4 (36.4%) | 5 (18.5%) |
Clinical trials | 15 (94%) | 7 (63.6%) | 22 (81.5%) | |
Randomized | 10 (63%) | 7 (64%) | 17 (63%) | |
Multicenter | 10 (63%) | 9 (82%) | 19 (70%) | |
Geographic level | International/national | 7 (44%) | 8 (73%) | 15 (56%) |
Regional | 9 (56%) | 3 (27%) | 12 (44%) | |
Purpose* | Diagnostic | 1 (6%) | 3 (27%) | 4 (15%) |
Observational | 0 (0%) | 2 (18%) | 2 (7%) | |
Therapeutic | 15 (94%) | 6 (55%) | 21 (78%) | |
Risk level α | A | 2 (13%) | 4 (36.4%) | 6 (22%) |
B | 4 (25%) | 3 (27%) | 7 (26%) | |
C | 3 (19%) | 3 (27%) | 6 (22%) | |
D | 7 (44%) | 1 (9%) | 8 (30%) | |
Clinical trial phase | 1 | 1 (7%) | 0 (0%) | 1 (4%) |
2 | 4 (27%) | 1 (14%) | 5 (23%) | |
3 | 7 (47%) | 6 (86%) | 13 (59%) | |
4 | 3 (20%) | 0 (0%) | 3 (14%) | |
Median number of patients included* | 60 | 355 | 80 | |
Q1 = 27 | Q1 = 78 | Q1 = 50 | ||
Q3 = 141 | Q3 = 700 | Q3 = 500 | ||
Median number of centers | 5 | 10 | 7 | |
Q1 = 1 | Q1 = 6 | Q1 = 1 | ||
Q3 = 10 | Q3 = 13 | Q3 = 12 | ||
Median planned duration of study (months) | 24 | 27 | 25 | |
Q1 = 16 | Q1 = 18 | Q1 = 16 | ||
Q3 = 40 | Q3 = 36 | Q3 = 36 | ||
Median planned patient follow up (days) | 137 | 60 | 91 | |
Q1 = 67 | Q1 = 12 | Q1 = 30 | ||
Q3 = 365 | Q3 = 112 | Q3 = 213 | ||
Median number of variables in CRF | 1,062 | 396 | 1011 | |
Q1 = 669 | Q1 = 153 | Q1 = 286 | ||
Q3 = 1,118 | Q3 = 1,567 | Q3 = 1,126 | ||
Median number of variables in database β | 65,928 | 304,929 | 76,692 | |
Q1 = 18,764 | Q1 = 35,250 | Q1 = 20,088 | ||
Q3 = 171,646 | Q3 = 625,865 | Q3 = 304,929 | ||
Median number of full pages in CRF* | 39 | 17 | 31 | |
Q1 = 28 | Q1 = 9 | Q1 = 17 | ||
Q3 = 44 | Q3 = 30 | Q3 = 44 |