Two-arm BOP2: Bayesian Optimal Phase II Two-arm Design

Objective:

Futility Monitoring

Superiority and Futility Monitoring

Endpoints:

Binary Efficacy

Binary Toxicity

Efficacy & Toxicity

Multiple Efficacy

Interims:

Sample sizes when interim analyses to be performed, seperated by space. The last number must be the total sample size.

Allocation Ratio (Experimental/Control)

Expected Response Rate:

Response Rate for Control

Response Rate for Experimental

Margin

Expected Toxicity Rate:

Toxicity Rate for Control

Toxicity Rate for Experimental

Margin

Expected Response Rate:

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Margin in Pr(CR)

Margin in Pr(CR/PR)

Type I Error Rate (One-sided):

Prior Distribution:

Use default noninformative prior with prior effective sample size = 1 (Recommended)

Control Arm:

Prob(Efficacy)

Prior Effective Sample Size

Experimental Arm:

Prob(Efficacy)

Prior Effective Sample Size

Control Arm:

Prob(Toxicity)

Prior Effective Sample Size

Experimental Arm:

Prob(Toxicity)

Prior Effective Sample Size

Simulation Parameters:

Number of Simulations

Seed of the Random Number Generator

Stopping Boundaries

Simulation Scenarios:

Scenario 2

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 3

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 4

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 5

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 6

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 7

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 8

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 9

Response Rate for Control Arm

Response Rate for Experimental Arm

Scenario 10

Response Rate for Control Arm

Response Rate for Experimental Arm

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 2

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 3

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 4

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 5

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 6

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 7

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 8

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 9

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

Scenario 10

Toxicity Rate for Control Arm

Toxicity Rate for Experimental Arm

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 2

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 3

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 4

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 5

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 6

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 7

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 8

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 9

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

Scenario 10

Pr(CR) for Control Arm

Pr(CR/PR) for Control Arm

Pr(CR) for Experimental Arm

Pr(CR/PR) for Experimental Arm

The maximum number of scenarios you can enter is 10

Seed of the Random Number Generator

Number of Simulations

Operating Characteristics

Note: Calculate the stopping boundaries before downloading the decision figure; otherwise, the download figure button is disabled.

Note: Calculate the stopping boundaries and run the simulation using the same endpoint before downloading the protocol template; otherwise, the download protocol button is disabled.

Download decision figure

Download protocol template

Download decision figure

Download protocol template

Download decision figure (eff1)

Download decision figure (eff2)

Download protocol template

Download decision figure (eff)

Download decision figure (tox)

Download protocol template

Zhao, Y., Yang, B., Lee, J. J., Wang, L., & Yuan, Y. (2022). Bayesian Optimal Phase II Design for Randomized Clinical Trials. Statistics in Biopharmaceutical Research, 14, 423-432

Two-arm BOP2: Bayesian Optimal Phase II Two-arm Design

PID: 1054; Version: V1.1.7.0 ; Last Updated: 07/01/2025

Yujie Zhao, Ying Yuan

Department of Biostatistics, The University of Texas MD Anderson Cancer Center

Trial Setting

Simulation

Protocol

Reference

Objective:

Endpoints:

Interims:

Sample sizes when interim analyses to be performed, seperated by space. The last number must be the total sample size.

Allocation Ratio (Experimental/Control)

Expected Response Rate:

Expected Toxicity Rate:

Expected Response Rate:

Type I Error Rate (One-sided):

Prior Distribution:

Prior Distribution:

Prior Distribution:

Prior Distribution:

Use default noninformative prior with prior effective sample size = 1 (Recommended)

Control Arm:

Experimental Arm:

Control Arm:

Experimental Arm:

Simulation Parameters:

Stopping Boundaries

Simulation Scenarios:

Scenario 2

Scenario 3

Scenario 4

Scenario 5

Scenario 6

Scenario 7

Scenario 8

Scenario 9

Scenario 10

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 2

Scenario 3

Scenario 4

Scenario 5

Scenario 6

Scenario 7

Scenario 8

Scenario 9

Scenario 10

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 2

Scenario 3

Scenario 4

Scenario 5

Scenario 6

Scenario 7

Scenario 8

Scenario 9

Scenario 10

The maximum number of scenarios you can enter is 10

Operating Characteristics

Note: Calculate the stopping boundaries before downloading the decision figure; otherwise, the download figure button is disabled.

Note: Calculate the stopping boundaries and run the simulation using the same endpoint before downloading the protocol template; otherwise, the download protocol button is disabled.

Zhao, Y., Yang, B., Lee, J. J., Wang, L., & Yuan, Y. (2022). Bayesian Optimal Phase II Design for Randomized Clinical Trials. Statistics in Biopharmaceutical Research, 14, 423-432