BOIN COMB: Bayesian Optimal Interval Design (BOIN) for Drug Combination Trials

Trial Name (Optional):

Simulation Setting

Method to enter simulation scenarios:

Type in

Upload scenario file

Enter Simulation Scenarios

Number of Simulations:

Set seed:

Number of simulations must be positive.

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

wrong input

Scenario 1:

Scenario 2:

Scenario 3:

Scenario 4:

Scenario 5:

Scenario 6:

Scenario 7:

Scenario 8:

Scenario 9:

Scenario 10:

Error:You already reached the maximum number of scenarios you can enter!

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

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Number of Simulations:

Set seed:

Number of simulations must be positive.

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)

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)

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

Trial Name (Optional):

Set seed

Enter the number of evaluable patients treated at each dose combination:
Enter the number of patients with toxicity at each dose combination:

Next Dose/Subtrial Information

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

Trial Name (Optional):

Enter the number of evaluable patients treated at each dose combination:
Enter the number of patients with toxicity at each dose combination:

Download MTD Report (PDF)

MTD Selection Result

1. Lin R. and Yin, G. (2015). Bayesian Optimal Interval Design for Dose Finding in Drug-combination Trials, Statistical Methods in Medical Research, DOI: 10.1177/0962280215594494.

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, clincanres-0592.

3. Zhang, L., & Yuan, Y. (2016). A practical Bayesian design to identify the maximum tolerated dose contour for drug combination trials. Statistics in medicine, 35(27), 4924-4936.

4. Yan, F., Zhang, L., Zhou, Y., Pan, H., Liu, S., & Yuan, Y. (2020). BOIN: an R package for designing single-agent and drug-combination dose-finding trials using Bayesian optimal interval designs. Journal of Statistical Software, 94(1), 1-32.

5. 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. (2025). Bayesian Optimal Interval (BOIN) Design for Phase I Clinical Trials (V2.6.3.0) [Computer software]. Available at https://www.trialdesign.org/.

BOIN COMB: Bayesian Optimal Interval Design (BOIN) for Drug Combination Trials

PID: 956 ; V2.6.3.0 ; Last Updated: 9/13/2023

Yanhong Zhou, Ruitao Lin, Suyu Liu, and Ying Yuan

Department of Biostatistics, MD Anderson Cancer Center

Trial Setting

Simulation

Trial Protocol

Next Dose/Subtrial

Select MTD

Reference

User guide for the BOIN COMB App

Design parameters:

Enter design parameters in the following panels.

Doses

Error: Dose Levels for Drug A must be Less than that of Drug B!

Drug A

Drug B

Number of Doses:

Target Probability

Sample Size

Overdose Control

Design Flow Chart

Decision Table

Simulation Setting

Enter Simulation Scenarios

Number of simulations must be positive.

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

Error:You already reached the maximum number of scenarios you can enter!

Number of simulations must be positive.

Operating Characteristics

Scenarios entered (Click "CSV" to save for later use if desired).

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

Next Dose/Subtrial Information

MTD Selection Result

1. Lin R. and Yin, G. (2015). Bayesian Optimal Interval Design for Dose Finding in Drug-combination Trials, Statistical Methods in Medical Research, DOI: 10.1177/0962280215594494.

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, clincanres-0592.

3. Zhang, L., & Yuan, Y. (2016). A practical Bayesian design to identify the maximum tolerated dose contour for drug combination trials. Statistics in medicine, 35(27), 4924-4936.

4. Yan, F., Zhang, L., Zhou, Y., Pan, H., Liu, S., & Yuan, Y. (2020). BOIN: an R package for designing single-agent and drug-combination dose-finding trials using Bayesian optimal interval designs. Journal of Statistical Software, 94(1), 1-32.

5. 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. (2025). Bayesian Optimal Interval (BOIN) Design for Phase I Clinical Trials (V2.6.3.0) [Computer software]. Available at https://www.trialdesign.org/.