BOP2: Bayesian Optimal Phase II Design with Simple and Complex Endpoints

Simulation Scenarios:

Scenario 2

Response Rate

Scenario 3

Response Rate

Scenario 4

Response Rate

Scenario 5

Response Rate

Scenario 6

Response Rate

Scenario 7

Response Rate

Scenario 8

Response Rate

Scenario 9

Response Rate

Scenario 10

Response Rate

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 2

Toxicity Rate

Scenario 3

Toxicity Rate

Scenario 4

Toxicity Rate

Scenario 5

Toxicity Rate

Scenario 6

Toxicity Rate

Scenario 7

Toxicity Rate

Scenario 8

Toxicity Rate

Scenario 9

Toxicity Rate

Scenario 10

Toxicity Rate

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 2

Pr(CR)

Pr(CR/PR)

Scenario 3

Pr(CR)

Pr(CR/PR)

Scenario 4

Pr(CR)

Pr(CR/PR)

Scenario 5

Pr(CR)

Pr(CR/PR)

Scenario 6

Pr(CR)

Pr(CR/PR)

Scenario 7

Pr(CR)

Pr(CR/PR)

Scenario 8

Pr(CR)

Pr(CR/PR)

Scenario 9

Pr(CR)

Pr(CR/PR)

Scenario 10

Pr(CR)

Pr(CR/PR)

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 1

Scenario 2

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 3

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 4

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 5

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 6

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 7

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 8

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 9

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

Scenario 10

Pr(Eff1)

Pr(Eff2)

Pr(Eff1 & Eff2)

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 1

Scenario 2

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 3

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 4

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 5

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 6

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 7

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 8

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 9

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

Scenario 10

Pr(Eff)

Pr(Tox)

Pr(Eff & Tox)

The maximum number of scenarios you can enter is 10

Simulation Scenarios:

Scenario 2

Median Survival Time

Scenario 3

Median Survival Time

Scenario 4

Median Survival Time

Scenario 5

Median Survival Time

Scenario 6

Median Survival Time

Scenario 7

Median Survival Time

Scenario 8

Median Survival Time

Scenario 9

Median Survival Time

Scenario 10

Median Survival Time

The maximum number of scenarios you can enter is 10

Number of Simulated Trials

Seed of the Random Number Generator

Operating Characteristics

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

Download protocol template

下载中文试验方案(word)

下载中文试验方案(html)

Download protocol template

下载中文试验方案(word)

下载中文试验方案(html)

Download protocol template

下载中文试验方案(word)

下载中文试验方案(html)

Download protocol template

下载中文试验方案(word)

下载中文试验方案(html)

Download protocol template

下载中文试验方案(word)

下载中文试验方案(html)

Download protocol template

下载中文试验方案(word)

下载中文试验方案(html)

Download protocol template

下载中文试验方案(word)

下载中文试验方案(html)

Endpoint: Binary Efficacy

Hypothesis:

Pr(Eff)

Pr(Tox)

Pr(Eff2)

Pr(Eff & Tox)

Pr(Eff1 & Eff2)

Pr(CR)

Pr(CR/PR)

Simulation Parameters:

Number of Simulations

Seed of the Random Number Generator

Animation Settings:

Delays to start (seconds)

Delays between frames (seconds)

Delays between trials (seconds)

Animation

Zhou, H., Lee, J. J., & Yuan, Y. (2017). BOP2: Bayesian optimal design for phase II clinical trials with simple and complex endpoints. Statistics in Medicine, 36: 3302-3314

Zhou, H., Chen, C., Sun, L., & Yuan, Y. (2020). Bayesian optimal phase II clinical trial design with time-to-event endpoint. Pharmaceutical Statistics, 19: 776-786

Chen, K., Zhou, H., Lee, J. J., & Yuan, Y. (2024). BOP2-TE: Bayesian optimal phase 2 design for jointly monitoring efficacy and toxicity with application to dose optimization. Journal of Biopharmaceutical Statistics, 1–16.

BOP2: Bayesian Optimal Phase II Design with Simple and Complex Endpoints

PID: 960; Version: V1.4.22.0 ; Last Updated: 12/16/2024

Heng Zhou, Yujie Zhao, Ying-Wei Kuo, Nan Chen, Kai Chen, Yanhong Zhou, J. Jack Lee and Ying Yuan

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

Trial Setting

Operating Characteristics

Protocol

Animation

Reference

Endpoints:

Interims:

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

Sample sizes when interim analyses to be performed, separated by space. The last number must be the total sample size. The total sample size must be the same for both efficacy and toxicity interims.

Efficacy

Toxicity

Null Hypothesis:

Null Hypothesis:

Null Hypothesis:

Null Hypothesis:

Null Hypothesis:

Null Hypothesis:

Alternative Hypothesis:

Alternative Hypothesis:

Alternative Hypothesis:

Alternative Hypothesis:

Alternative Hypothesis:

Alternative Hypothesis:

Type I Error Rate (One-sided):

strictly control type I error <= nominal value

strictly control type I error <= nominal value

Prior Specifiction

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

Use default vague prior with prior effective sample size = 0.05 (Recommended)

Simulation Parameters:

Simulation Parameters:

Stopping Boundaries

*999/-999 means that this endpoint will not be used to make go/no-go decision at the interim

*999 means that this endpoint will not be used to make go/no-go decision at the interim

*-999 means that this endpoint will not be used to make go/no-go decision at the interim

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

Simulation Scenarios:

Scenario 1

Scenario 2

Scenario 3

Scenario 4

Scenario 5

Scenario 6

Scenario 7