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

PID: 1150 ; V1.0.7.0 ; Last Updated: 04/07/2025

Yixuan Zhao, Ying Yuan,Ying-Wei Kuo

Department of Biostatistics, MD Anderson Cancer Center

Enter design parameters in the following panels.

Doses & Sample Size of Dose Escalation



Backfiling

Close a dose for backfilling if the number of patients assigned to the dose reaches \(n_{cap}\), where \(n_{cap}\) =

Target Probability




Overdose Control

Eliminate dose \(j\) if\(\ Pr\) (\(p_{_j}\)> \(\phi\) | \(data\)) > \(p_{_E}\)





Simulation

Enter Simulation Scenarios




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









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


Current Dose Escalation Cohort

1. Dose level of the current dose escalation cohort:

2. Is the current dose esclation cohort fully filled?

3. Is the DLT assessment completed on the current dose escalation cohort?

4. Is the dose escalation ended?

Please enter the trial data:


Dose level
# of patients treated
# of patients completed DLT assessment
# of patients with DLT
# of patients with response


Enter trial data:


Dose level
Number of evaluable patients treated
Number of patients with dose limiting toxicity