Table 6.
Simulation results: logistic dose-toxicity: Loge(DLT rate/(1−DLT rate)) = −5.96641 + 0.013713*dose: effect of starting at lower doses on the accuracy of MTD selection.
| Design | Median sample size when starting dose is dose level −3 | Accuracy of MTD selection when starting dose is dose level −3 (% of times dose level 3 is selected as MTD) | % of patients underdosed when starting dose is dose level −3 | Median sample size when starting dose is dose level −2 | Accuracy of MTD selection when starting dose is dose level −2 (% of times dose level 3 is selected as MTD) | % of patients underdosed when starting dose is dose level −2 | Median sample size when starting dose is dose level −1 | Accuracy of MTD Selection when starting dose is dose level −1 (% of times dose level 3 is selected as MTD) | % of Patients underdosed when starting dose is dose level −1 | Median sample size when starting dose is dose level 1 | Accuracy of MTD Selection when starting dose is dose level 1 (% of times dose level 3 is selected as MTD) | % of patients underdosed when starting dose is dose level 1 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 + 3 | 21 | 67.79% | 70.84% | 18 | 67.11% | 66.16% | 15 | 67.82% | 59.74% | 12 | 68.05% | 50.30% |
| 2 + 4 | 16 | 70.45% | 63.96% | 14 | 70.51% | 59.06% | 12 | 69.76% | 52.45% | 10 | 69.62% | 43.23% |
| 4 + 4 a | 32 | 79.59% | 67.02% | 28 | 79.54% | 62.21% | 24 | 79.53% | 55.66% | 20 | 79.65% | 46.08% |
| 5 + 5 a | 40 | 69.48% | 69.18% | 35 | 69.05% | 64.48% | 30 | 69.80% | 58.22% | 25 | 69.19% | 48.83% |
| 3 + 3+3 | 24 | 75.92% | 68.45% | 21 | 75.85% | 63.66% | 18 | 76.09% | 57.14% | 15 | 75.9% | 47.72% |
| Accelerated titration | 9 | 63.35% | 52.96% | 8 | 63.79% | 47.60% | 7 | 63.00% | 41.04% | 6 | 62.98% | 32.06% |
| mTPI | 30 (max) | 77.3% | 59.71% | 27 (max) | 77.5% | 54.49% | 24 (max) | 77.8% | 48.72% | 21 (max) | 76.1% | 41.9% |
| TEQR | 30 | 70% | 62.91% | 27 | 69% | 59.17% | 24 | 71% | 54.22% | 21 | 70% | 46.74% |
| BOIN | 30 (max) | 72.2% | 65.89% | 27 (max) | 71% | 62.08% | 24 (max) | 72% | 57.5% | 21 (max) | 72.3% | 49.76% |
| CRM | 30 (max) | 75% | 60.88% | 27 (max) | 76% | 56.2% | 24 (max) | 76% | 50.73% | 21 (max) | 76% | 43.97% |
| EWOC | 30 (max) | 70.2% | 52.76% | 27 (max) | 70.85% | 45.76% | 24 (max) | 65.3% | 47.4% | 21 (max) | 70.45% | 40.06% |
The sample size is an output for the A + B escalation only designs. For the model based designs, the sample size is an output for the TEQR design and we use the same sample size obtained from the TEQR design for the other model based designs. For the CRM design, a prior DLT rate of 0.01, 0.05 and 0.1 are used at dose levels −1, −2 and −3.