Table 1 Design characteristics for simulations
From: Challenges in implementing model-based phase I designs in a grant-funded clinical trials unit
Design characteristic | Specifics |
|---|---|
Stopping rule | 6, 8, 10 patients on a dose, no early stopping |
Maximum sample size | Stages A1 and A2: 15, 20, 25, Stage B: 20, 25, 30 |
Distribution of toxicities | Uniform, triangular with the mode half-way through the dose-limiting toxicity window |
Dose escalation | With or without overdosing allowed |
Dose allocation | No dose skipping when escalating but no restrictions in de-escalating |
Accrual rate (patient/weeks) | 1/4, 1/6, 1/8 |