Table 1:
Selected characteristics of phase I designs
| Design characteristics | Rule-based | Model-assisted | Model-based |
|---|---|---|---|
| Examples | 3+3 Up/down | mTPI, mTPI-2 Keyboard BOIN | CRM EWOC BLRM |
| Pre-determined dose escalation rules set up before study | Yes | Yes | No |
| Computationally intensive, repeated estimation of dose-toxicity curve | No | No | Yes |
| Targets any pre-specified DLT rate | No | Yes | Yes |
| Number of patients treated at MTD can be >6 | No | Yes | Yes |
| Rapid dose escalation | No | Yes | Yes |
| Good operating characteristics relative to sample size | No | Yes | Yes |
| Allocates a high percentage of patients to the MTD | No | Yes | Yes |
| Provides overdose control | Yes | Yes | Yes |
| Won’t escalate the dose when the latest treated patient experiences toxicity; and will never deescalate the dose when the latest treated patient does not experience toxicity | No | Yes | Yes |
DLT=dose-limiting toxicity; MTD=maximum tolerated dose; CRM=continual reassessment method; EWOC= escalation with overdose control; BOIN=Bayesian optimal interval; mTPI=modified toxicity probability interval; BLRM=Bayesian logistic regression model