Time-to-Event Keyboard Design for Phase I Clinical Trials

How to Use the TITE-Keyboard App

Doses

Number of doses:

Starting dose level:

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

Target Probability

Target Toxicity Probability \(\phi\) :

Sample Size and Accrual Rate

Cohort size:

Number of cohort:

DLT assessment window:

Accrual rate / month:

Use the default uniform prior for the time to toxicity.

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

Trimester 1

Trimester 2

Overdose Control

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

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

Check the box to impose a more stringent safety stopping rule:

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

Suspend accrual if more than 50% of patients are pending at the current dose (recommended).

Suspend the accrual if the percentage of pending patients is greater than:

Decision Table
Design Flow Chart

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) =

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 trial protocol as html file

Download trial protocol as Word file

Download Figure 1 in protocol

Download Table 1 in protocol

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 nonpending patients at the current dose

# of pending patients at the current dose

Pending patient

Follow-up time (days)

ESS/WESS Calculation Result

PID: 1006 : v1.2.1.0 ; Last Updated: 06/16/2020

Time-to-Event Keyboard Design for Phase I Clinical Trials

Ruitao Lin, Yanhong Zhou, and Ying Yuan

Department of Biostatistics, MD Anderson Cancer Center

Trial Setting

Simulation

Trial Protocol

ESS Calculator

Reference

How to Use the TITE-Keyboard App

Doses

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

Target Probability

Sample Size and Accrual Rate

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

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

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

Pending patient

Follow-up time (days)

ESS/WESS Calculation Result

Lin, R. and Yuan, Y. (2019). Time-to-Event Model-Assisted Designs for Dose-Finding Trials with Delayed Toxicity. Biostatistics in press

PID: 1006 : v1.2.1.0 ; Last Updated: 06/16/2020

Time-to-Event Keyboard Design for Phase I Clinical Trials

Ruitao Lin, Yanhong Zhou, and Ying Yuan

Department of Biostatistics, MD Anderson Cancer Center

Trial Setting

Simulation

Trial Protocol

ESS Calculator

Reference

How to Use the TITE-Keyboard App

Doses

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

Target Probability

Sample Size and Accrual Rate

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.

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

Pending patient

Follow-up time (days)

ESS/WESS Calculation Result

Lin, R. and Yuan, Y. (2019). Time-to-Event Model-Assisted Designs for Dose-Finding Trials with Delayed Toxicity. Biostatistics in press