B1 |
Let j* denote the highest dose level that has been tried. If and j* is not the highest dose in the trial, escalate the dose to dj*+1 for treating the next cohort of patients; otherwise, proceed to step B2. |
B2 |
Given the observed interim data D collected in both stages I and II, determine the admissible dose set . If no dose is admissible, terminate the trial and no dose should be selected as the OBD. Otherwise, assign the next cohort of patients to the admissible dose (i.e., ∈ ) that has the largest posterior mean utility, which can be pre-tabulated. |
B3 |
Repeat steps B1 and B2 until reaching the prespecified maximum sample size N or the number of patients treated at one of the doses reaches s2 (> s1), and then select the OBD as the admissible dose (i.e., ∈ ) that has the largest posterior mean utility. For most trials, a value between 18 to 24 is a reasonable choice for s2. |