Table 2.
Pivotal trials of targeted anticancer drugs between domestic and imported drugs.
| Characteristic | Domestic drugs, N (%) | Imported drugs, N (%) | P value |
|---|---|---|---|
| Total of pivotal trial | 21 | 27 | NA |
| Pivotal trials per indications, median (range) | 1 (1, 1) | 1 (1, 3) | 0.04 |
| Participants per trials, median (IQR) | 341 (217, 412) | 345 (206, 588) | 0.43 |
| Study design | |||
| Randomized | 13 (61) | 22 (81) | 0.19 |
| Single-arma | 8 (38) | 5 (19) | |
| Clinical trial phase | |||
| Phase 3 | 14 (67) | 22 (81) | 0.48 |
| Phase 2 | 6 (29) | 4 (14) | |
| Phase 1 | 1 (4) | 1 (4) | |
| Type of Blinding | |||
| Double | 7 (33) | 13 (48) | 0.38 |
| Open label | 14 (67) | 14 (52) | |
| Type of control | |||
| Active | 6 (29) | 11 (41) | 0.27 |
| Placebo | 6 (28) | 11 (41) | |
| Dose comparison | 1 (5) | 0 (0) | |
| Historical control | 8 (38) | 5 (19) |
IQR, interquartile range; NA, not available.
a
One of the domestic anticancer drugs for a dose-comparison clinical trial design was considered as single-arm design.