Study characteristics | All studies n=94 | Study source | |
---|---|---|---|
AIFA websitea n=66 | ClinicalTrials.govb n=28 | ||
Primary purpose, n (%) | Â | Â | Â |
Treatment | 86 (91%) | 60 (91%) | 26(93%) |
Prevention | 8 (9%) | 6 (9%) | 2 (7%) |
Phase, n (%) | Â | Â | Â |
1 | 3 (4%) | 3 (5%) | - |
1/2 | 1 (1%) | 1 (2%) | Â |
2 | 29 (34%) | 20 (31%) | 9 (43%) |
2/3 | 19 (22%) | 13 (20%) | 6 (29%) |
3 | 32 (38%) | 26 (40%) | 6 (29%) |
4 | 1 (1%) | 1 (2%) | - |
Not reported | 1 | 1 | - |
Not applicable | 8 | 1 | 7 |
Sample sizec, n (%) | Â | Â | Â |
1-100 | 26 (30%) | 14 (23%) | 12 (46%) |
101-1000 | 53 (60%) | 39 (63%) | 14 (54%) |
>1000 | 9 (10%) | 9 (14%) | - |
Not reported | 6 | 4 | 2 |
Study design | Â | Â | Â |
Single group | 20 (22%) | 9 (14%) | 11 (39%) |
Parallel group | 69 (74%) | 55 (85%) | 14 (50%) |
Cross over | 1 (1%) | - | 1 (4%) |
Sequential | 3 (3%) | 1 (1%) | 2 (7%) |
Not reported | 1 | 1 | - |
Randomization, n (%) | Â | Â | Â |
Yes | 70 (76%) | 55 (85%) | 15 (56%) |
No | 22 (24%) | 10 (15%) | 12 (44%) |
Not reported | 2 | 1 | 1 |
Masking, n (%) | Â | Â | Â |
Yes | 31 (33%) | 25 (38%) | 6 (21%) |
No | 62 (67%) | 40 (62%) | 22 (79%) |
Not reported | 1 | 1 | - |
Multicenter study, n (%) | Â | Â | Â |
Yes | 74 (80%) | 56 (88%) | 18 (64%) |
No | 18 (20%) | 8 (12%) | 10 (36%) |
Not reported | 2 | 2 | - |
International study, n (%) | Â | Â | Â |
Yes | 37 (40%) | 31 (48%) | 6 (21%) |
No | 55 (60%) | 33 (52%) | 22 (79%) |
Not reported | 2 | 2 | - |
Study sponsor, n (%) | Â | Â | Â |
Industry | 32 (34%) | 27 (41%) | 5 (18%) |
No industry | 62 (66%) | 39 (59%) | 23 (82%) |