Bayesian Optimal INterval (BOIN) Design for Single-Agent and Drug- Combination Phase I Clinical Trials
Generate the optimal dose escalation and deescalation boundaries for c...
Generate operating characteristics for drug combination trials
Generate operating characteristics for single agent trials
Determine the dose combination for the next cohort of new patients for...
Determine the starting dose and the dose-searching space for next subt...
Plot the flowchart and simulation results for BOIN designs
Generate descriptive summary for objects returned by other functions
Select the maximum tolerated dose (MTD) or MTD contour for drug combin...
Select the maximum tolerated dose (MTD) for single agent trials
Generate descriptive summary for objects returned by other functions
The Bayesian optimal interval (BOIN) design is a novel phase I clinical trial design for finding the maximum tolerated dose (MTD). It can be used to design both single-agent and drug-combination trials. The BOIN design is motivated by the top priority and concern of clinicians when testing a new drug, which is to effectively treat patients and minimize the chance of exposing them to subtherapeutic or overly toxic doses. The prominent advantage of the BOIN design is that it achieves simplicity and superior performance at the same time. The BOIN design is algorithm-based and can be implemented in a simple way similar to the traditional 3+3 design. The BOIN design yields an average performance that is comparable to that of the continual reassessment method (CRM, one of the best model-based designs) in terms of selecting the MTD, but has a substantially lower risk of assigning patients to subtherapeutic or overly toxic doses. For tutorial, please check Yan et al. (2020) <doi:10.18637/jss.v094.i13>.