Bayesian Optimal Interval (BOIN) Design for Phase I Clinical Trials

Simulation

Trial Name (Optional):

Method to enter simulation scenarios:

Type in

Upload scenario file

Simulate 3+3 design for comparison:

Match maximum sample size between BOIN and 3+3

Perform cohort expansion on 3+3 to match the sample size of BOIN

Match the sample size of BOIN to that of 3+3

Enter Simulation Scenarios

Number of Simulations:

Set Seed:

For each scenario, enter true toxicity rate of each dose level:

Please upload simulation scenario file with the template: csv file template

Browse...

Number of Simulations:

Set Seed:

Operating Characteristics

Please make sure that you have set up Trial Setting and Simulation before generating the protocol.

Protocol template:

Download Trial protocol(html)

Download Trial protocol(word)

Download flowchart

中文试验方案模板

生成试验方案模板(html)

生成试验方案模板(word)

下载流程图

Animation

Trial Name (Optional):

Scenario:

Choose between Scenario 1 - 4

True toxicity rate of each dose level:

Simulation Parameters:

Number of Simulations

Seed of the random number generator

Animation Settings:

Delays to start (\(seconds\))

Delays between frames (\(seconds\))

Delays between trials (\(seconds\))

Animation

First dose level is too high. This trial is stopped.

Check the box to confirm that design parameters have been entered under Trial Setting.

Trial Name (Optional):

Enter trial data:

Dose level

Number of evaluable patients treated

Number of patients with dose limiting toxicity

Download MTD Report (PDF)

MTD Selection Result

1. Liu S. and Yuan, Y. (2015). Bayesian optimal interval designs for phase I clinical trials, Journal of the Royal Statistical Society: Series C , 64, 507-523.

2. Yuan, Y., Hess, K. R., Hilsenbeck, S. G., & Gilbert, M. R. (2016). Bayesian optimal interval design: a simple and well-performing design for phase I oncology trials. Clinical Cancer Research, 22(17), 4291-4301.

3. Zhou, H., Yuan, Y., & Nie, L. (2018). Accuracy, safety, and reliability of novel phase I trial designs. Clinical Cancer Research, 24(18), 4357-4364.

4. Zhou, Y., Lin, R., Kuo, Y. W., Lee, J. J., & Yuan, Y. (2021). BOIN Suite: A Software Platform to Design and Implement Novel Early-Phase Clinical Trials. JCO Clinical Cancer Informatics, 5, 91-101.

Cite the software:

Zhou, Y., Liu, Y., Yuan, Y., & Lee, J.J., Zhou, H., Chen, N., & Kuo, Y. (2024). Bayesian Optimal Interval (BOIN) Design for Phase I Clinical Trials (V3.0.9.0) [Computer software]. Available at https://www.trialdesign.org/.

Bayesian Optimal Interval (BOIN) Design for Phase I Clinical Trials

PID: 979 ; V3.0.9.0 ; Last Updated: 08/26/2024

Yanhong Zhou, Suyu Liu, Ying Yuan, J. Jack Lee, Heng Zhou, Nan Chen, and Ying-Wei Kuo

Department of Biostatistics, MD Anderson Cancer Center

Trial Setting

Simulation

Trial Protocol

Animation

Select MTD

Reference

User guide for the BOIN App

Design parameters:

Enter design parameters in the following panels.

Doses & Sample Size

Target Probability

Overdose Control

Design Flow Chart

Decision Table

Simulation

Enter Simulation Scenarios

For each scenario, enter true toxicity rate of each dose level:

Operating Characteristics

Here is the scenarios entered

Here is the scenarios uploaded

Please make sure that you have set up Trial Setting and Simulation before generating the protocol.

Protocol template:

中文试验方案模板

Animation

Scenario:

Choose between Scenario 1 - 4

True toxicity rate of each dose level:

Simulation Parameters:

Animation Settings:

Animation

First dose level is too high. This trial is stopped.

Enter trial data:

Dose level

Number of evaluable patients treated

Number of patients with dose limiting toxicity

MTD Selection Result

1. Liu S. and Yuan, Y. (2015). Bayesian optimal interval designs for phase I clinical trials, Journal of the Royal Statistical Society: Series C , 64, 507-523.

2. Yuan, Y., Hess, K. R., Hilsenbeck, S. G., & Gilbert, M. R. (2016). Bayesian optimal interval design: a simple and well-performing design for phase I oncology trials. Clinical Cancer Research, 22(17), 4291-4301.

3. Zhou, H., Yuan, Y., & Nie, L. (2018). Accuracy, safety, and reliability of novel phase I trial designs. Clinical Cancer Research, 24(18), 4357-4364.

4. Zhou, Y., Lin, R., Kuo, Y. W., Lee, J. J., & Yuan, Y. (2021). BOIN Suite: A Software Platform to Design and Implement Novel Early-Phase Clinical Trials. JCO Clinical Cancer Informatics, 5, 91-101.

Cite the software:

Zhou, Y., Liu, Y., Yuan, Y., & Lee, J.J., Zhou, H., Chen, N., & Kuo, Y. (2024). Bayesian Optimal Interval (BOIN) Design for Phase I Clinical Trials (V3.0.9.0) [Computer software]. Available at https://www.trialdesign.org/.