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Related Experiment Video

Updated: Jun 14, 2025

Design and Optimization Strategies of a High-Performance Vented Box

Design and Optimization Strategies of a High-Performance Vented Box

Published on: June 9, 2023

Tips for Accelerating BOIN Design.

Masahiro Kojima¹, Wu Wende², Henry Zhao²

¹Biometrics Department, Research Division, Kyowa Kirin Co., Ltd. Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-004, Japan. kojima.masahiro@ism.ac.jp.

Therapeutic Innovation & Regulatory Science

|September 2, 2024

Summary

We developed an accelerated Bayesian Optimal Interval (BOIN) design to expedite early-phase clinical trials. This new method matches the speed of the traditional 3+3 design, reducing study duration and patient numbers.

Keywords:

3 + 3 Design Accelerated BOIN design

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Last Updated: Jun 14, 2025

Design and Optimization Strategies of a High-Performance Vented Box

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A Modeling and Simulation Method for Preliminary Design of an Electro-Variable Displacement Pump

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Area of Science:

Clinical Trials
Biostatistics
Drug Development

Background:

The standard 3+3 design is widely used for dose escalation but can be lengthy.
The BOIN design offers statistical advantages but has faced adoption barriers due to perceived longer study durations and larger sample sizes.

Purpose of the Study:

To introduce an accelerated BOIN design for Phase I clinical trials.
To enable the BOIN design to achieve a pace comparable to the 3+3 design.
To demonstrate the applicability of the BOIN design in a company predominantly using the 3+3 design.

Main Methods:

An accelerated BOIN design was developed by incorporating an efficient stopping criterion.
The proposed method involves terminating dose escalation if 6 patients at the current dose are evaluable and the decision is to stay.
For lower doses, smaller cohort sizes were considered feasible if non-clinical studies showed no safety concerns.

Main Results:

The accelerated BOIN design demonstrated a -2.43% average difference in correct Maximum Tolerated Dose (MTD) selection compared to the standard BOIN design.
The accelerated BOIN design reduced average study duration by 14.8 months.
The average sample size was reduced by 9.22 patients compared to the standard BOIN design.

Conclusions:

The accelerated BOIN design provides a viable alternative to the 3+3 design for dose escalation.
This accelerated approach maintains statistical rigor while improving trial efficiency.
The findings support wider adoption of the BOIN design in early-phase oncology trials.