| Characteristic |
Category |
Bioequivalence & Bioavailability Trials |
| Ongoing (n = 227) |
Completed (n = 2,161) |
| Study phase, n (%) |
Phase 0, 1, 1/2 |
82 (36) |
1,625 (75) |
| |
Phase 2, 2/3 |
31 (14) |
51 (2) |
| |
Phase 3, 4 |
57 (25) |
120 (6) |
| |
Unknown / missing |
57 (25) |
365 (17) |
| Allocation status, n (%) |
Randomized |
172 (76) |
1,955 (90) |
| |
Non-randomized |
21 (9) |
94 (4) |
| |
Unknown / missing |
34 (15) |
112 (5) |
| Blinding, n (%) |
Open |
141 (62) |
1,751 (81) |
| |
Single blind |
24 (11) |
114 (5) |
| |
Double blind |
62 (27) |
252 (12) |
| |
Unknown / missing |
0 (0) |
44 (2) |
| Interventional group, n (%) |
Single group |
55 (24) |
151 (7) |
| |
Parallel |
98 (43) |
249 (12) |
| |
Cross-over |
69 (30) |
1,707 (79) |
| |
Factorial |
5 (2) |
8 (<1) |
| |
Unknown / missing |
0 (0) |
46 (2) |
| Endpoint classification, n (%) |
Bioavailability |
47 (21) |
418 (19) |
| |
Bioequivalence |
108 (48) |
1,270 (59) |
| |
Efficacy |
14 (6) |
26 (1) |
| |
Pharmacokinetics and/or pharmacodynamics |
16 (7) |
239 (11) |
| |
Safety |
14 (6) |
64 (3) |
| |
Safety / efficacy |
18 (8) |
20 (1) |
| |
Unknown / missing |
10 (4) |
124 (6) |
| Primary purpose, n (%) |
Treatment |
125 (55) |
911 (42) |
| |
Basic science |
28 (12) |
317 (15) |
| |
Prevention |
20 (9) |
61 (3) |
| |
Diagnostic |
17 (7) |
20 (1) |
| |
Health services research |
3 (1) |
16 (1) |
| |
Supportive care |
6 (3) |
7 (<1) |
| |
Screening |
0 (0) |
7 (<1) |
| |
Missing |
28 (12) |
822 (38) |
| Sex, n (%) |
Female only |
21 (9) |
113 (5) |
| |
Male only |
20 (9) |
424 (20) |
| |
Both |
186 (82) |
1,616 (75) |
| |
Unknown / missing |
0 (0) |
8 (<1) |
| Age groups, n (%) |
Children only |
17 (7) |
30 (1) |
| |
Children and adults |
23 (10) |
48 (2) |
| |
Adults only |
187 (82) |
2,083 (96) |
| Expected sample size, median (IQR) |
50 (24 – 104) |
32 (24 – 48) |
|
