BOIN: An R Package for Designing Single-Agent and Drug-Combination Dose-Finding Trials Using Bayesian Optimal Interval Designs

Abstract

This article describes the R package BOIN, which implements a recently developed methodology for designing single-agent and drug-combination dose-finding clinical trials using Bayesian optimal interval designs (Liu and Yuan 2015; Yuan, Hess, Hilsenbeck, and Gilbert 2016). The BOIN designs are novel "model-assisted" phase I trial designs that can be implemented simply and transparently, similar to the 3 + 3 design, but yield excellent performance comparable to those of more complicated, model-based designs. The BOIN package provides tools for designing, conducting, and analyzing single-agent and drug-combination dose-finding trials.

Keywords

• maximum tolerated dose
• dose finding
• phase i trials
• model-assisted design
• bayesian adaptive design