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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