## [1] "RuleDesign"

Design

Dose recommendation

The dose recommended for the next cohort will be chosen using the “Three Plus Three” rule.

  • If no toxicities have been reported at the current dose level, escalate by one dose level.
  • If the observed toxicity rate at the current dose level is exactly 1/3 and no more than three participants treated at the current dose level are evaluable, remain at the current dose level.
  • Otherwise, recommend that the trial stops and identify the MTD as dose level immediately below the current one.

Cohort size

A constant size of 3 participants.

Observed data

No participants are yet evaluable.

The dose grid is 5, 10, 15, 25, 35, 50 and 80.

Starting dose

The starting dose is 5.