Table 1.
Characteristics of included trial protocols. Overall and by field (oncology and non-oncology).
| Overall (n = 106) | Oncology trials (n = 58) | Non-oncology trials (n = 48) | |
|---|---|---|---|
| Sample size (median and IQR) | 36 (20–64) | 30 (18–45) | 48 (29–72) |
| Center, n (%) | |||
| Multi-center | 54 (51.0) | 34 (58.6) | 20 (41.7) |
| Single-center | 33 (31.1) | 14 (24.1) | 19 (39.6) |
| Unclear | 19 (17.9) | 10 (17.2) | 9 (18.8) |
| Funding, n (%) | |||
| Industry | 71 (67.0) | 41 (70.7) | 30 (62.5) |
| Non-industry | 32 (30.2) | 16 (27.6) | 16 (33.3) |
| Unclear | 3 (2.8) | 1 (1.7) | 2 (4.2) |
| Field, n (%) | |||
| Oncology | 58 (54.7) | 58 (100) | 0 (0) |
| Non-oncology | 48 (45.3) | 0 (0) | 48 (100) |
| Randomisation, n (%) | |||
| No | 71 (67.0) | 55 (94.8) | 16 (33.3) |
| Yes | 35 (33.0) | 3 (5.2) | 32 (66.7) |
| Trial design, n (%) | |||
| Rule-based | 55 (51.9) | 42 (72.4) | 13 (27.1) |
| SAD and MAD/SAD/MAD | 20 (18.9) | 0 (0) | 20 (41.7) |
| Model-assisted | 7 (6.6) | 7 (12.1) | 0 (0) |
| Model-based | 4 (3.7) | 4 (6.9) | 0 (0) |
| Others | 20 (18.9) | 5 (8.6) | 15 (31.2) |
IQR: interquartile range; SAD and MAD: single ascending dose and multiple ascending dose.