Methods
Both clinician- and patient-reported DLT, termed C-DLT and P-DLT, respectively, are binary outcomes. Estimation is based on separate models for the probability of C-DLT and the probability of P-DLT, as well as the accumulated C-DLT and P-DLT data at each dose level, to sequentially allocate each new patient cohort. For general application, consider a Phase I trial evaluating The posterior mean for the probability of outcome At each accrual decision, we use the estimated probabilities 