Simulation output
DLTs
Of particular interest in simulating operating characteristics is the accuracy of the method under an assumed set of true DLT probabilities and the target DLT rate for each endpoint. Accuracy is typically measured by the percentage of simulated trials in which the true MTD is recommended as the MTD at the conclusion of the study. This is commonly termed the percentage of correct selection (PCS). Also of interest is the safety of the design, which is typically evaluated by how patients are allocated. Safety can be assessed through observing how many patients were allocated, on average, to dose levels at and around the true MTD, as well as by how many patients, on average were treated above the true MTD. Based on the simulation input provided by the user, the application will produce operating characteristics for the Bayesian PRO-CRM using the statistical parameters specified above. The results output:The percentage of trials in which each dose was selected as the MTD.The average number of NCI-CTCAE DLTs observed at each dose level.The average number of PRO-CTCAE DLTs observed at each dose level.The average number of patients treated at each dose level.The percentage of trials stopped for NCI-CTCAE safety.The percentage of trials stopped for PRO-CTCAE safety.The skeleton of the working model used.As an example, consider the input specifications in Output for the simulation component of the PRO-CRM web application.