Time-to-event Bayesian Optimal Interval (TITE-BOIN) Design for Phase I Clinical Trials

Trial Name (Optional):

Simulation Setup

Time to toxicity

(a) Distribution of the time to toxicity:

Uniform Weibull Log-logistic

(b) Degree of late-onset

Pr(DLT occurs in the late half of assessment window) =

Simulate Rolling Six Design for Comparison

Scenarios

Method to enter simulation scenarios:

Type in

Upload scenario file

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.

Download protocol template:

html template

Word template

Figure 1

Table 1

生成中文试验模板：

html 模板

Word 模板

图一

Trial Name (Optional):

DLT assessment window (days):

Prior for time to toxicity:

Uniform Informative

Prior toxicity probabilities in the assessment period (sum to 1)

Trimester 1

Trimester 2

# of pending patients at the current dose

Pending patient

Follow-up time (days)

STFT/WSTFT Calculation Result

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. Yuan, Y., Lin, R., Li, D., Nie, L. and Warren, K.E. (2018). Time-to-event Bayesian Optimal Interval Design to Accelerate Phase I Trials. Clinical Cancer Research, 24(20): 4921-4930.

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., Zhou, H., Lin, R., & Yuan, Y. (2025). Time-to-event Bayesian Optimal Interval (TITE-BOIN) Design for Phase I Clinical Trials (V2.5.2.0) [Computer software]. Available at https://www.trialdesign.org/.

Time-to-event Bayesian Optimal Interval (TITE-BOIN) Design for Phase I Clinical Trials

PID: 976 ; V2.5.2.0 ; Last Updated: 10/22/2024

Yanhong Zhou, Heng Zhou, Kai Chen, Ruitao Lin, and Ying Yuan

Department of Biostatistics, MD Anderson Cancer Center

Trial Setting

Simulation

Trial Protocol

STFT Calculator

Select MTD

Reference

User guide for the TITE-BOIN 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

Accrual Rate & Suspension Rule

Prior toxicity probabilities in the assessment period (sum to 1)

Overdose Control

Decision Table

Design Flow Chart

Simulation Setup

Time to toxicity

(b) Degree of late-onset

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.

Download protocol template:

生成中文试验模板：

Prior toxicity probabilities in the assessment period (sum to 1)

Pending patient

Follow-up time (days)

STFT/WSTFT Calculation Result

Enter trial data:

Dose level

Number of evaluable patients treated

Number of patients with dose limiting toxicity

MTD Selection Result

1. Yuan, Y., Lin, R., Li, D., Nie, L. and Warren, K.E. (2018). Time-to-event Bayesian Optimal Interval Design to Accelerate Phase I Trials. Clinical Cancer Research, 24(20): 4921-4930.

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., Zhou, H., Lin, R., & Yuan, Y. (2025). Time-to-event Bayesian Optimal Interval (TITE-BOIN) Design for Phase I Clinical Trials (V2.5.2.0) [Computer software]. Available at https://www.trialdesign.org/.