Simulation input
The simulation function generates the operating characteristics of the Bayesian PRO-CRM based upon the user specifying the following set of input parameters.An assumed set of true NCI-CTCAE DLT probabilities, separated by commas (i.e., 0.05, 0.15).An assumed set of true PRO-CTACE DLT probabilities, separated by commas (i.e., 0.18, 0.35).The target NCI-CTACE DLT probability (i.e., 0.20).The target PRO-CTACE DLT probability (i.e., 0.55).The cohort size required before the next model-based update. Cohort size may be 1, 2, or 3 patients (i.e., 3).The maximum sample size for the study. This number should be a multiple of the cohort size entered above (i.e., 15).The number of simulations. A minimum of 1000 is recommended (i.e., 10,000).The index of the starting dose level. Note: The index of lowest dose level is always 1. If the design allows for ‘minus’ dose levels (i.e. −2, −1 dose levels), then the index of the starting dose should account for these lower levels (i.e. if a −1 dose level is allowed, the index of the starting dose is 2).The total number of patients treated on any dose required to stop the trial. At any point in the trial, if the recommendation is to assign the next cohort to a dose that already has the entered number of patients treated on the dose, the study is stopped and the recommended dose is declared the optimal dose. If the entered number is larger than the maximum sample size, each trial will accrue to the maximum sample size (i.e., 16).The confidence level for safety stopping rule at the lowest study dose level (i.e., 0.80).The seed of the random number generator (i.e., 34,895).The variance of the normal prior for the NCI-DLT probability model (i.e., 1.60).The variance of the normal prior for the PRO-DLT probability model (i.e., 1.58).The simulation results will be generated by clicking the 