Table 3.
Simulation Study: PCD = probability of selecting the correct dose. Ntox = average number of toxicities. N = average sample size. Dur is the average trial duration in years. MTD ↓, MTD and MTD ↑ denotes the average number of patients treated below, at, and above the maximum tolerated dose, respectively.
| Scenario | Design | PCD | Ntox | N | Dur | MTD ↓ | MTD = | MTD ↑ |
|---|---|---|---|---|---|---|---|---|
| 6 | 3 + 3 | 64.1 | 2.9 | 9.4 | 1.7 | 43.0 | 37.7 | 19.3 |
| UD | 74.9 | 8.2 | 24.0 | 4.0 | 23.2 | 53.0 | 23.8 | |
| IR-A | 87.4 | 5.8 | 21.3 | 3.2 | 23.2 | 64.3 | 12.5 | |
| IR-B | 92.2 | 6.6 | 24.0 | 4.0 | 20.0 | 66.6 | 13.5 | |
| TITE-IR | 87.7 | 8.6 | 24.0 | 1.5 | 25.8 | 47.6 | 26.7 | |
| 7 | 3 + 3 | 19.7 | 2.6 | 7.7 | 1.4 | 69.7 | 21.3 | 9.0 |
| UD | 28.3 | 8.1 | 24.0 | 4.1 | 48.2 | 34.4 | 17.4 | |
| IR-A | 33.4 | 5.6 | 17.0 | 2.5 | 59.0 | 27.9 | 13.1 | |
| IR-B | 40.3 | 8.0 | 24.0 | 4.1 | 53.7 | 30.7 | 15.6 | |
| TITE-IR | 38.9 | 8.3 | 24.0 | 1.5 | 48.3 | 28.6 | 23.1 | |
| 8 | 3 + 3 | 38.2 | 2.0 | 20.2 | 3.6 | 70.2 | 19.8 | 0 |
| UD | 47.1 | 2.8 | 24.0 | 4.1 | 75.5 | 24.5 | 0 | |
| IR-A | 60.7 | 2.9 | 24.0 | 4.1 | 72.6 | 27.4 | 0 | |
| IR-B | 60.6 | 3.0 | 24.0 | 4.1 | 72.8 | 27.2 | 0 | |
| TITE-IR | 46.0 | 1.9 | 24.0 | 1.5 | 85.6 | 14.4 | 0 | |
| 9 | 3 + 3 | 9.9 | 2.8 | 13.6 | 2.4 | 91.7 | 5.7 | 2.6 |
| UD | 14.0 | 5.0 | 24.0 | 4.1 | 89.7 | 8.2 | 2.1 | |
| IR-A | 19.3 | 4.5 | 21.5 | 3.5 | 89.7 | 8.0 | 2.3 | |
| IR-B | 21.4 | 5.0 | 24.0 | 4.1 | 89.0 | 8.6 | 2.3 | |
| TITE-IR | 22.0 | 5.0 | 24.0 | 1.5 | 88.6 | 7.8 | 3.6 | |
| 10 | 3 + 3 | 27.7 | 2.8 | 15.2 | 2.7 | 75.3 | 12.7 | 12.0 |
| UD | 42.4 | 4.6 | 24.0 | 4.1 | 63.2 | 21.6 | 15.2 | |
| IR-A | 37.2 | 4.3 | 22.5 | 3.7 | 65.6 | 18.7 | 15.7 | |
| IR-B | 43.0 | 4.7 | 24.0 | 4.1 | 63.7 | 20.2 | 16.1 | |
| TITE-IR | 39.2 | 4.4 | 24.0 | 1.5 | 68.6 | 16.9 | 14.5 |