Benefits of Bayesian Optimal Interval (BOIN) Design for Early-phase Oncology Trials 

Early-phase oncology trials, particularly Phase I trials, typically determine the maximum tolerated
dose (MTD) to ensure patient safety. While the traditional 3+3 design is common for its simplicity,
the Bayesian Optimal Interval (BOIN) design offers greater flexibility and efficiency. This white paper
explores the advantages of the BOIN design and compares it to the 3+3 approach using practical
examples.

This whitepaper gives insights on

• Rules-based vs. Model-based vs. Model-assisted Designs
• Project Optimus and the Importance of Early-phase Oncology Trials
• Bayesian Optimal Interval (BOIN) Design: A Practical Example