Bayesian Optimal Interval Design with Informative Prior (iBOIN) for Phase I Clinical Trials

User guide for the iBOIN App

Trial Name (Optional):

Design parameters:

Type in Upload using previously saved input

Enter design parameters in the following panels.

Upload the previously saved input (a .csv file)

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Doses & Sample Size

Number of doses:

Starting dose level:

Error: Starting dose level must be less than the number of doses

Cohort size:

Number of cohort:

Stop trial if the number of patients assigned to single dose reaches \(m\) and the decision is to stay, where \(m\) =

Target Probability

Target toxicity probability \(\phi\) :

Use the default alternatives to minimize decision error (recommended).

Alternatives under which decision errors are minimized:

Perform accelerated titration:

No Yes

Overdose Control

Eliminate dose \(j\) if\(\ Pr\) (\(p_j\)> \(\phi\) | \(data\)) > \(p_E\)

Use the default cutoff (recommended) \(p_E\) =

Check to impose a more stringent safety stopping rule on the lowest dose.

Stop the trial if\(\ Pr\) (\(p_1\)> \(\phi\) | \(data\)) > \(p_E\) - \(\delta\), where \(\delta\) is

Check to ensure \(\hat p_{_{MTD}} \leq \) de-escalation boundary, where \(\hat p_{_{MTD}}\) is the isotonic estimate of the DLT probability for the dose selected as the MTD.

Prior Specification

Enter prior toxicity probability and effective sample size (ESS) at each dose level:

Check the box to use robust prior

Save Input

Design Flow Chart
Decision Table

Trial Name (Optional):

Simulation

Incorporate prior information to select MTD in simulation?

Yes No

Method to enter simulation scenarios:

Type in Upload scenario file

Simulate 3+3 design for comparison:

Perform cohort expansion to match maximum sample size between BOIN and 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

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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

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

Trial Name (Optional):

Check to incorporate prior when selecting MTD

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. Zhou, Y., Lee, J. J., Wang, S., Bailey, S., & Yuan, Y. (2020). Incorporating historical information to improve phase I clinical trial designs. arXiv preprint arXiv:2004.12972.

2. 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., Yuan, Y., & Lee, J.J.(2025). Bayesian Optimal Interval Design with Informative Prior (iBOIN) for Phase I Clinical Trials (V1.6.2.0) [Computer software]. Available at https://www.trialdesign.org/.

Bayesian Optimal Interval Design with Informative Prior (iBOIN) for Phase I Clinical Trials

PID: 1040 ; V1.6.2.0 ; Last Updated: 11/29/2022

Yanhong Zhou, Ying Yuan, J. Jack Lee

Department of Biostatistics, MD Anderson Cancer Center

Trial Setting

Simulation

Trial Protocol

Select MTD

Reference

User guide for the iBOIN App

Design parameters:

Enter design parameters in the following panels.

Doses & Sample Size

Error: Starting dose level must be less than the number of doses

Target Probability

Overdose Control

Prior Specification

Enter prior toxicity probability and effective sample size (ESS) at each dose level:

Design Flow Chart

Decision Table

Simulation

Enter Simulation Scenarios

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

Operating Characteristics

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

Enter trial data:

Dose level

Number of evaluable patients treated

Number of patients with dose limiting toxicity

MTD Selection Result

1. Zhou, Y., Lee, J. J., Wang, S., Bailey, S., & Yuan, Y. (2020). Incorporating historical information to improve phase I clinical trial designs. arXiv preprint arXiv:2004.12972.

2. 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., Yuan, Y., & Lee, J.J.(2025). Bayesian Optimal Interval Design with Informative Prior (iBOIN) for Phase I Clinical Trials (V1.6.2.0) [Computer software]. Available at https://www.trialdesign.org/.

Bayesian Optimal Interval Design with Informative Prior (iBOIN) for Phase I Clinical Trials

PID: 1040 ; V1.6.2.0 ; Last Updated: 11/29/2022

Yanhong Zhou, Ying Yuan, J. Jack Lee

Department of Biostatistics, MD Anderson Cancer Center

Trial Setting

Simulation

Trial Protocol

Select MTD

Reference

User guide for the iBOIN App

Design parameters:

Enter design parameters in the following panels.

Doses & Sample Size

Error: Starting dose level must be less than the number of doses

Target Probability

Overdose Control

Prior Specification

Enter prior toxicity probability and effective sample size (ESS) at each dose level:

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

Enter trial data:

Dose level

Number of evaluable patients treated

Number of patients with dose limiting toxicity

MTD Selection Result

1. Zhou, Y., Lee, J. J., Wang, S., Bailey, S., & Yuan, Y. (2020). Incorporating historical information to improve phase I clinical trial designs. arXiv preprint arXiv:2004.12972.

2. 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., Yuan, Y., & Lee, J.J.(2025). Bayesian Optimal Interval Design with Informative Prior (iBOIN) for Phase I Clinical Trials (V1.6.2.0) [Computer software]. Available at https://www.trialdesign.org/.