BOP2-DC: Bayesian Optimal Phase II Design with Dual-criterion Decision-making

Endpoints:

Binary Efficacy

Efficacy & Toxicity

Multiple Efficacy

Time To Event

Interims:

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

Accrual rate

Follow-up time after last patient enrolled

Parameters:

Response rate that is deemed futile

Response rate that is deemed effective

Lower reference value $LRV$

Minimal clinically meaningful value $CMV$

Parameters:

Median survival time that is deemed futile

Alternative Hypothesis:

Median survival time that is deemed effective

Lower reference value $LRV$

Minimal clinically meaningful value $CMV$

False Decision Rate:

False go rate

False no-go rate

False consider rate

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)

Prob(Efficacy)

Prior effective sample size

Prob(Eff1)

Prob(Eff2)

Prob(Eff1 & Eff2)

Prior effective sample size

Prob(Eff)

Prob(Tox)

Prob(Eff & Tox)

Prior effective sample size

Simulation Parameters:

Number of simulations

Seed of the random number generator

Stopping Boundaries
Stopping Boundaries (Figure)

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

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 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 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 button is disabled.

Download protocol template

Download decision figure

Download posterior probability table

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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

Download decision figure (eff)

Download decision figure (tox)

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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

Download decision figure (eff1)

Download decision figure (eff2)

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

BOP2-DC: Bayesian Optimal Phase II Design with Dual-criterion Decision-making

PID: 1093; Version: V1.0.6.0 ; Last Updated: 8/3/2022

Yujie Zhao and Ying Yuan

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

Trial Setting

Operating Characteristics

Protocol

Reference

Endpoints:

Interims:

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

Parameters:

Parameters:

Alternative Hypothesis:

False Decision Rate:

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:

Stopping Boundaries

Stopping Boundaries (Figure)

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 1

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

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 button is disabled.

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 button is disabled.

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 button is disabled.

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

Zhao, Y., Li, D., Liu, R., & Yuan, Y. (2022+). Bayesian optimal phase II designs with dual-criterion decision-making framework. Submitted