Package 'basksim'

Title: Simulation-Based Calculation of Basket Trial Operating Characteristics
Description: Provides a unified syntax for the simulation-based comparison of different single-stage basket trial designs with a binary endpoint and equal sample sizes in all baskets. Methods include the designs by Baumann et al. (2024) <doi:10.48550/arXiv.2309.06988>, Fujikawa et al. (2020) <doi:10.1002/bimj.201800404>, Berry et al. (2020) <doi:10.1177/1740774513497539>, Neuenschwander et al. (2016) <doi:10.1002/pst.1730> and Psioda et al. (2021) <doi:10.1093/biostatistics/kxz014>. For the latter three designs, the functions are mostly wrappers for functions provided by the packages 'bhmbasket' and 'bmabasket'.
Authors: Lukas Baumann [aut, cre] , Lukas Sauer [ctb] (0000-0002-1340-9994)
Maintainer: Lukas Baumann <[email protected]>
License: GPL (>= 3)
Version: 1.0.0
Built: 2024-10-10 06:42:53 UTC
Source: CRAN

Help Index


Adjust Lambda

Description

Adjust Lambda

Usage

adjust_lambda(design, ...)

Arguments

design

An object created with one of the setup functions.

...

Further arguments.

Details

The default method for adjust_lambda uses a combination of uniroot and grid search and calls toer in every iteration. For methods implemented in the bhmbasket package there are separate methods that are computationally more efficient.

Value

A list containing the greatest estimated value for lambda with prec_digits decimal places which controls the family wise error rate at level alpha (one-sided) and the estimated family wise error rate for the estimated lambda.

Examples

design <- setup_cpp(k = 3, p0 = 0.2)
adjust_lambda(design = design, n = 20, alpha = 0.05,
  design_params = list(tune_a = 1, tune_b = 1), iter = 1000)

Adjust Lambda for the BHM Design

Description

Adjust Lambda for the BHM Design

Usage

## S3 method for class 'bhm'
adjust_lambda(
  design,
  n,
  p1 = NULL,
  alpha = 0.05,
  design_params = list(),
  iter = 1000,
  n_mcmc = 10000,
  prec_digits = 3,
  data = NULL,
  ...
)

Arguments

design

An object created with one of the setup functions.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

alpha

The one-sided significance level.

design_params

A list of params that is specific to the class of design.

iter

The number of iterations in the simulation. Is ignored if data is specified.

n_mcmc

Number of MCMC samples.

prec_digits

Number of decimal places that are considered when adjusting lambda.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the greatest estimated value for lambda with prec_digits decimal places which controls the family wise error rate at level alpha (one-sided) and the estimated family wise error rate for the estimated lambda.

Examples

design <- setup_bhm(k = 3, p0 = 0.2, p_target = 0.5)
adjust_lambda(design = design, n = 15,
  design_params = list(tau_scale = 1), iter = 100, n_mcmc = 5000)

Adjust Lambda

Description

Adjust Lambda

Usage

## Default S3 method:
adjust_lambda(
  design,
  n,
  p1 = NULL,
  alpha = 0.05,
  design_params = list(),
  iter = 1000,
  prec_digits = 3,
  data = NULL,
  ...
)

Arguments

design

An object created with one of the setup functions.

n

The sample size per basket.

p1

Probabilities under the alternative hypothesis. If NULL then the type 1 error rate under the global null hypothesis is calculated.

alpha

The one-sided significance level.

design_params

A list of params that is specific to the class of design.

iter

The number of iterations in the simulation. Is ignored if data is specified.

prec_digits

Number of decimal places that are considered when adjusting lambda.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Details

It is recommended to use data and then use the same simulated data set for all further calculations. If data = NULL then new data is generated in each step of the algorithm, so lambda doesn't necessarily protect the family wise error rate for different simulated data due to Monte Carlo simulation error.

Value

A list containing the greatest estimated value for lambda with prec_digits decimal places which controls the family wise error rate at level alpha (one-sided) and the estimated family wise error rate for the estimated lambda.

Examples

# Example for a basket trial with Fujikawa's Design
design <- setup_fujikawa(k = 3, p0 = 0.2)
adjust_lambda(design = design, n = 20, alpha = 0.05,
  design_params = list(epsilon = 2, tau = 0), iter = 1000)

Adjust Lambda for the EXNEX Design

Description

Adjust Lambda for the EXNEX Design

Usage

## S3 method for class 'exnex'
adjust_lambda(
  design,
  n,
  p1 = NULL,
  alpha = 0.05,
  design_params = list(),
  iter = 1000,
  n_mcmc = 10000,
  prec_digits = 3,
  data = NULL,
  ...
)

Arguments

design

An object created with one of the setup functions.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

alpha

The one-sided significance level.

design_params

A list of params that is specific to the class of design.

iter

The number of iterations in the simulation. Is ignored if data is specified.

n_mcmc

Number of MCMC samples.

prec_digits

Number of decimal places that are considered when adjusting lambda.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the greatest estimated value for lambda with prec_digits decimal places which controls the family wise error rate at level alpha (one-sided) and the estimated family wise error rate for the estimated lambda.

Examples

design <- setup_exnex(k = 3, p0 = 0.2)
adjust_lambda(design = design, n = 15,
  design_params = list(tau_scale = 1, w = 0.5), iter = 100, n_mcmc = 5000)

Calculate the Expected Number of Correct Decisions for a Basket Trial Design

Description

Calculate the Expected Number of Correct Decisions for a Basket Trial Design

Usage

ecd(
  design,
  n,
  p1,
  lambda,
  design_params = list(),
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object created with one of the setup functions.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

design_params

A list of params that is specific to the class of design.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A numeric value.

Examples

# Example for a basket trial with Fujikawa's Design
design <- setup_fujikawa(k = 3, p0 = 0.2)
ecd(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  design_params = list(epsilon = 2, tau = 0), iter = 1000)

Simulate Data Based on a Binomial Distribution

Description

Simulate Data Based on a Binomial Distribution

Usage

get_data(k, n, p, iter, type = c("matrix", "bhmbasket"))

Arguments

k

The number of baskets.

n

The sample size per basket.

p

Probabilities used to simulate the data

iter

The number of iterations in the simulation. Is ignored if data is specified.

type

Type of output. Use bhmbasket for the BHM and EXNED design and matrix for everything else.

Details

For type = "bhmbasket" this is simply a wraper for bhmbasket::simulateScenarios.

Value

If type = "matrix" then a matrix is returned, if type = "bhmbasket" then an element with class scenario_list.

Examples

get_data(k = 3, n = 20, p = c(0.2, 0.2, 0.5), iter = 1000)

Get Details of a Basket Trial Simulation

Description

Get Details of a Basket Trial Simulation

Usage

get_details(design, ...)

Arguments

design

An object created with one of the setup functions.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors of all baskets and the family-wise error rate. For some methods the mean limits of HDI intervals are also returned.

Examples

# Example for a basket trial with Fujikawa's Design
design <- setup_fujikawa(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  epsilon = 2, tau = 0, iter = 100)

Get Details of a BHM Basket Trial Simulation

Description

Get Details of a BHM Basket Trial Simulation

Usage

## S3 method for class 'bhm'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  tau_scale,
  iter = 1000,
  n_mcmc = 10000,
  data = NULL,
  ...
)

Arguments

design

An object of class bhm.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

tau_scale

Standard deviation of the half normal prior distribution for the variance of the thetas.

iter

The number of iterations in the simulation. Is ignored if data is specified.

n_mcmc

Number of MCMC samples.

data

An object of class scenario_list as returned by the function bhmbasket::simulateScenarios.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate.

Examples

design <- setup_bhm(k = 3, p0 = 0.2, p_target = 0.5)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5),
  lambda = 0.95, tau_scale = 1, iter = 100)

Get Details of a BMA Basket Trial Simulation

Description

Get Details of a BMA Basket Trial Simulation

Usage

## S3 method for class 'bma'
get_details(design, n, p1 = NULL, lambda, pmp0, iter = 1000, data = NULL, ...)

Arguments

design

An object of class bma.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

pmp0

Power parameter that is used to compute prior probabilities. See bma for details.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, and mean squared errors for all baskets as well as the family-wise error rate.

Examples

design <- setup_bma(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = 0.5, lambda = 0.95, pmp0 = 1,
  iter = 100)

Get Details of a Basket Trial Simulation with the Calibrated Power Prior Design

Description

Get Details of a Basket Trial Simulation with the Calibrated Power Prior Design

Usage

## S3 method for class 'cpp'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  tune_a,
  tune_b,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class cpp.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

tune_a

First tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

tune_b

Second tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate.

Examples

design <- setup_cpp(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tune_a = 1, tune_b = 1, iter = 100)

Get Details of a Basket Trial Simulation with the Global Calibrated Power Prior Design

Description

Get Details of a Basket Trial Simulation with the Global Calibrated Power Prior Design

Usage

## S3 method for class 'cppglobal'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  tune_a,
  tune_b,
  epsilon,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class cppgen.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

tune_a

First tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

tune_b

Second tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

epsilon

Tuning parameter that determines the amount of borrowing based on overall heterogeneity.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate.

Examples

design <- setup_cppglobal(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tune_a = 1, tune_b = 1, epsilon = 2, iter = 100)

Get Details of a Basket Trial Simulation with the EXNEX Design

Description

Get Details of a Basket Trial Simulation with the EXNEX Design

Usage

## S3 method for class 'exnex'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  tau_scale,
  w,
  iter = 1000,
  n_mcmc = 10000,
  data = NULL,
  ...
)

Arguments

design

An object of class exnex.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

tau_scale

Standard deviation of the half normal prior exchangeability distribution for the variance of the thetas.

w

Fixed prior weight for the exchangeability part of the model.

iter

The number of iterations in the simulation. Is ignored if data is specified.

n_mcmc

Number of MCMC samples.

data

An object of class scenario_list as returned by the function bhmbasket::simulateScenarios.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate.

Examples

design <- setup_exnex(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tau_scale = 1, w = 0.5, iter = 100)

Get Details of a Basket Trial Simulation with Fujikawa's Design

Description

Get Details of a Basket Trial Simulation with Fujikawa's Design

Usage

## S3 method for class 'fujikawa'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  epsilon,
  tau,
  logbase = 2,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class fujikawa.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

epsilon

Tuning parameter that determines the amount of borrowing. See setup_fujikawa).

tau

Tuning parameter that determines how similar the baskets have to be that information is shared. See setup_fujikawa).

logbase

Tuning parameter. The base of the logarithm that is used to calculate the Jensen-Shannon divergence.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate and the experiment-wise power.

Examples

design <- setup_fujikawa(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  epsilon = 2, tau = 0, iter = 100)

Get Details of a Basket Trial Simulation with the Power Prior Design Based on Global JSD Weights

Description

Get Details of a Basket Trial Simulation with the Power Prior Design Based on Global JSD Weights

Usage

## S3 method for class 'jsdglobal'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  eps_pair,
  tau = 0,
  eps_all,
  logbase = 2,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class jsdgen.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

eps_pair

Tuning parameter that determines the amount of borrowing based on pairwise similarity.

tau

Tuning parameter that determines how similar the baskets have to be that information is shared.

eps_all

Tuning parameter that determines the amount of borrowing based on overall heterogeneity.

logbase

Tuning parameter. The base of the logarithm that is used to calculate the Jensen-Shannon divergence.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate.

Examples

design <- setup_jsdglobal(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  eps_pair = 2, eps_all = 2, iter = 100)

Get Details of a Basket Trial Simulation with the MML Design

Description

Get Details of a Basket Trial Simulation with the MML Design

Usage

## S3 method for class 'mml'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class cpp.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate.

Examples

design <- setup_mml(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tune_a = 1, tune_b = 1, iter = 100)

Get Details of a Basket Trial Simulation with the Global MML Design

Description

Get Details of a Basket Trial Simulation with the Global MML Design

Usage

## S3 method for class 'mmlglobal'
get_details(
  design,
  n,
  p1 = NULL,
  lambda,
  level = 0.95,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class mmlglobal.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

level

Level of the credibility intervals.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A list containing the rejection probabilites, posterior means, mean squared errors and mean limits of HDI intervals for all baskets as well as the family-wise error rate.

Examples

design <- setup_mmlglobal(k = 3, p0 = 0.2)
get_details(design = design, n = 20, p1 = 0.5, lambda = 0.95, iter = 100)

Get Results for Simulation of Basket Trial Designs

Description

Get Results for Simulation of Basket Trial Designs

Usage

get_results(design, ...)

Arguments

design

An object created with one of the setup functions.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

# Example for a basket trial with Fujikawa's Design
design <- setup_fujikawa(k = 3, p0 = 0.2)
get_results(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  epsilon = 2, tau = 0, iter = 100)

Get Results for Simulation of a Basket Trial with the BHM Design

Description

Get Results for Simulation of a Basket Trial with the BHM Design

Usage

## S3 method for class 'bhm'
get_results(
  design,
  n,
  p1 = NULL,
  lambda,
  tau_scale,
  iter = 1000,
  n_mcmc = 10000,
  data = NULL,
  ...
)

Arguments

design

An object of class bhm.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

tau_scale

Standard deviation of the half normal prior distribution for the variance of the thetas.

iter

The number of iterations in the simulation. Is ignored if data is specified.

n_mcmc

Number of MCMC samples.

data

An object of class scenario_list as returned by the function bhmbasket::simulateScenarios.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_bhm(k = 3, p0 = 0.2, p_target = 0.5)
get_results(design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tau_scale = 1, iter = 100)

Get Results for Simulation of a Basket Trial with the BMA Design

Description

Get Results for Simulation of a Basket Trial with the BMA Design

Usage

## S3 method for class 'bma'
get_results(design, n, p1 = NULL, lambda, pmp0, iter = 1000, data = NULL, ...)

Arguments

design

An object of class bma.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

pmp0

Power parameter that is used to compute prior probabilities. See bma for details.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_bma(k = 3, p0 = 0.2)
get_results(design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  pmp0 = 1, iter = 100)

Get Results for Simulation of a Basket Trial with a Calibrated Power Prior Design

Description

Get Results for Simulation of a Basket Trial with a Calibrated Power Prior Design

Usage

## S3 method for class 'cpp'
get_results(
  design,
  n,
  p1 = NULL,
  lambda,
  tune_a,
  tune_b,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class cpp.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

tune_a

First tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

tune_b

Second tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_cpp(k = 3, p0 = 0.2)
get_results(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tune_a = 1, tune_b = 1, iter = 100)

Get Results for Simulation of a Basket Trial with a Global Calibrated Power Prior Design

Description

Get Results for Simulation of a Basket Trial with a Global Calibrated Power Prior Design

Usage

## S3 method for class 'cppglobal'
get_results(
  design,
  n,
  p1 = NULL,
  lambda,
  tune_a,
  tune_b,
  epsilon,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class cppgen.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

tune_a

First tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

tune_b

Second tuning parameter that determines the amount of borrowing based on pairwise similarity between baskets.

epsilon

Tuning parameter that determines the amount of borrowing based on overall heterogeneity.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_cppglobal(k = 3, p0 = 0.2)
get_results(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tune_a = 1, tune_b = 1, epsilon = 2, iter = 100)

Get Results for Simulation of a Basket Trial with the EXNEX Design

Description

Get Results for Simulation of a Basket Trial with the EXNEX Design

Usage

## S3 method for class 'exnex'
get_results(
  design,
  n,
  p1 = NULL,
  lambda,
  tau_scale,
  w,
  iter = 1000,
  n_mcmc = 10000,
  data = NULL,
  ...
)

Arguments

design

An object of class exnex.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

tau_scale

Standard deviation of the half normal prior exchangeability distribution for the variance of the thetas.

w

Fixed prior weight for the exchangeability part of the model.

iter

The number of iterations in the simulation. Is ignored if data is specified.

n_mcmc

Number of MCMC samples.

data

An object of class scenario_list as returned by the function bhmbasket::simulateScenarios.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_exnex(k = 3, p0 = 0.2)
get_results(design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  tau_scale = 1, w = 0.5, iter = 100)

Get Results for Simulation of a Basket Trial with Fujikawa's Design

Description

Get Results for Simulation of a Basket Trial with Fujikawa's Design

Usage

## S3 method for class 'fujikawa'
get_results(
  design,
  n,
  p1 = NULL,
  lambda,
  epsilon,
  tau,
  logbase = 2,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class fujikawa.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

epsilon

Tuning parameter that determines the amount of borrowing. See setup_fujikawa).

tau

Tuning parameter that determines how similar the baskets have to be that information is shared. See setup_fujikawa).

logbase

Tuning parameter. The base of the logarithm that is used to calculate the Jensen-Shannon divergence.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_fujikawa(k = 3, p0 = 0.2)
get_results(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  epsilon = 2, tau = 0, iter = 100)

Get Results for Simulation of a Basket Trial with the Power Prior Design Based on Global JSD Weights

Description

Get Results for Simulation of a Basket Trial with the Power Prior Design Based on Global JSD Weights

Usage

## S3 method for class 'jsdglobal'
get_results(
  design,
  n,
  p1 = NULL,
  lambda,
  eps_pair,
  tau = 0,
  eps_all,
  logbase = 2,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object of class jsdgen.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

eps_pair

Tuning parameter that determines the amount of borrowing based on pairwise similarity.

tau

Tuning parameter that determines how similar the baskets have to be that information is shared.

eps_all

Tuning parameter that determines the amount of borrowing based on overall heterogeneity.

logbase

Tuning parameter. The base of the logarithm that is used to calculate the Jensen-Shannon divergence.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_jsdglobal(k = 3, p0 = 0.2)
get_results(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  eps_pair = 2, eps_all = 2, iter = 100)

Get Results for Simulation of a Basket Trial with the MML Design

Description

Get Results for Simulation of a Basket Trial with the MML Design

Usage

## S3 method for class 'mml'
get_results(design, n, p1 = NULL, lambda, iter = 1000, data = NULL, ...)

Arguments

design

An object of class mml.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_mml(k = 3, p0 = 0.2)
get_results(design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  iter = 100)

Get Results for Simulation of a Basket Trial with the Global MML Design

Description

Get Results for Simulation of a Basket Trial with the Global MML Design

Usage

## S3 method for class 'mmlglobal'
get_results(design, n, p1 = NULL, lambda, iter = 1000, data = NULL, ...)

Arguments

design

An object of class mmlglobal.

n

The sample size per basket.

p1

Probabilities used for the simulation. If NULL then all probabilities are set to p0.

lambda

The posterior probability threshold.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A matrix of results with iter rows. A 0 means, that the null hypothesis that the response probability exceeds p0 was not rejected, a 1 means, that the null hypothesis was rejected.

Examples

design <- setup_mmlglobal(k = 3, p0 = 0.2)
get_results(design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  iter = 100)

Create a Scenario Matrix

Description

Creates a default scenario matrix.

Usage

get_scenarios(design, p1)

Arguments

design

An object created with one of the setup functions.

p1

Probability under the alternative hypothesis.

Details

get_scenarios creates a default scenario matrix that can be used for opt_design. The function creates k + 1 scenarios, from a global null to a global alternative scenario.

Value

A matrix with k rows and k + 1 columns.

Examples

design <- setup_fujikawa(k = 3, p0 = 0.2)
get_scenarios(design = design, p1 = 0.5)

Optimize a Basket Trial Design

Description

Optimize a Basket Trial Design

Usage

opt_design(
  design,
  n,
  alpha,
  design_params = list(),
  scenarios,
  prec_digits,
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object created with one of the setup functions.

n

The sample size per basket.

alpha

The one-sided significance level.

design_params

A list of params that is specific to the class of design.

scenarios

A matrix of scenarios.

prec_digits

Number of decimal places that are considered when adjusting lambda.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A list of data matrices generated with get_data. The list elements have to correspond to the columsn of scenarios.

...

Further arguments.

Value

A matrix with the expected number of correct decisions.

Examples

design <- setup_fujikawa(k = 3, p0 = 0.2)
scenarios <- get_scenarios(design, p1 = 0.5)

# Without simulated data
opt_design(design, n = 20, alpha = 0.05, design_params =
  list(epsilon = c(1, 2), tau = c(0, 0.5)), scenarios = scenarios,
  prec_digits = 3)

# With simulated data
scenario_list <- as.list(data.frame(scenarios))
data_list <- lapply(scenario_list,
  function(x) get_data(k = 3, n = 20, p = x, iter = 1000))
opt_design(design, n = 20, alpha = 0.05, design_params =
  list(epsilon = c(1, 2), tau = c(0, 0.5)), scenarios = scenarios,
  prec_digits = 3, data = data_list)

Setup BHM Design Object

Description

Setup BHM Design Object

Usage

setup_bhm(k, p0, p_target, mu_mean = NULL, mu_sd = 100)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

p_target

The response rate of interest. See details.

mu_mean

Mean of the normal prior distribution for the mean of the thetas. See details.

mu_sd

Standard deviation of the normal prior distribution for the mean of the thetas.

Details

The class bhm implements the Bayesian Hierarchical Model proposed by Berry et al. (2013). Methods for this class are mostly wrappers for functions from the package bhmbasket.

In the BHM the thetas of all baskets are modeled, where theta_i = logit(p_i) - logit(p_target). These thetas are assumed to come from a normal distribution with mean mu_mean and standard deviation mu_sd. If mu_mean = NULL then mu_mean is determined as logit(p0) - logit(p_target), hence the mean of the normal distribution corresponds to the null hypothesis.

Value

An S3 object of class bhm

References

Berry, S. M., Broglio, K. R., Groshen, S., & Berry, D. A. (2013). Bayesian hierarchical modeling of patient subpopulations: efficient designs of phase II oncology clinical trials. Clinical Trials, 10(5), 720-734.

Examples

design_bhm <- setup_bhm(k = 3, p0 = 0.2, p_target = 0.5)

Setup bma Design Object

Description

Creates an object of class bma.

Usage

setup_bma(k, p0, shape1 = 1, shape2 = 1)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

shape1

First common shape parameter of the beta prior.

shape2

Second common shape parameter of the beta prior.

Details

The class bma implements the Bayesian Model Averaging design by Pisoda et al. (2021). Functions for this class are mostly wrappers for functions of the bmabasket package.

Value

An S3 object of class bma

References

Psioda, M. A., Xu, J., Jiang, Q. I., Ke, C., Yang, Z., & Ibrahim, J. G. (2021). Bayesian adaptive basket trial design using model averaging. Biostatistics, 22(1), 19-34.

Examples

design_bma <- setup_bma(k = 3, p0 = 0.2)

Setup Calibrated Power Prior Design Object

Description

Setup Calibrated Power Prior Design Object

Usage

setup_cpp(k, p0, shape1 = 1, shape2 = 1)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

shape1

First common shape parameter of the beta prior.

shape2

Second common shape parameter of the beta prior.

Details

The class cpp implements a version of the power prior design, in which the amount of information that is shared between baskets is determined by the Kolmogorov-Smirnov test statistic between baskets (which is equivalent to the absolut difference in response rates).

Value

An S3 object of class cpp

References

Baumann, L., Sauer, L., & Kieser, M. (2024). A basket trial design based on power priors. arXiv:2309.06988.

Examples

design_cpp <- setup_cpp(k = 3, p0 = 0.2)

Setup Global Calibrated Power Prior Design Object

Description

Setup Global Calibrated Power Prior Design Object

Usage

setup_cppglobal(k, p0, shape1 = 1, shape2 = 1)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

shape1

First common shape parameter of the beta prior.

shape2

Second common shape parameter of the beta prior.

Details

The class cppglobal implements a version of the power prior design, in which the amount of information that is shared between baskets is determined by the Kolmogorov-Smirnov test statistic between basekts and a function based on response rate differences that quantifies the overall heterogeneity.

Value

An S3 object of class cppglobal

References

Baumann, L., Sauer, L., & Kieser, M. (2024). A basket trial design based on power priors. arXiv:2309.06988.

Examples

design_cppglobal <- setup_cppglobal(k = 3, p0 = 0.2)

Setup EXNEX Design Object

Description

Setup EXNEX Design Object

Usage

setup_exnex(
  k,
  p0,
  basket_mean = NULL,
  basket_sd = 100,
  mu_mean = NULL,
  mu_sd = 100
)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

basket_mean

Mean of the normal prior distribution of the individual thetas (NEX part). See details.

basket_sd

Standard deviation of the normal prior distribution of the individual thetas (NEX part).

mu_mean

Mean of the normal prior exchangeability distribution for the mean of the thetas (EX part). See details.

mu_sd

Standard deviation of the normal prior exchangeability distribution for the mean of the thetas (EX part).

Details

The class exnex implements the EXNEX model proposed by Neuenschwander et al. (2016). Methods for this class are mostly wrappers for functions from the package bhmbasket.

In the EXNEX model the thetas of all baskets are modeled as a mixture of individual models and a Bayesian Hierarchical Model with a fixed mixture weight w. If mu_mean and basket_mean are NULL then they are set to logit(p0). Note that Neuenschwander et al. (2016) use different prior means and standard deviations. The default values here are used for better comparison with the BHM model (see setup_bhm).

Value

An S3 object of class exnex

References

Neuenschwander, B., Wandel, S., Roychoudhury, S., & Bailey, S. (2016). Robust exchangeability designs for early phase clinical trials with multiple strata. Pharmaceutical statistics, 15(2), 123-134.

Examples

design_exnex <- setup_exnex(k = 3, p0 = 0.2)

Setup Fujikawa Design Object

Description

Setup Fujikawa Design Object

Usage

setup_fujikawa(k, p0, shape1 = 1, shape2 = 1)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

shape1

First common shape parameter of the beta prior.

shape2

Second common shape parameter of the beta prior.

Details

The class fujikawa implements a design by Fujikawa et al. (2020) in which information is shared based on the pairwise similarity between baskets which is quantified using the Jensen-Shannon divergence between the individual posterior distributions between baskets.

Value

An S3 object of class fujikawa

References

Fujikawa, K., Teramukai, S., Yokota, I., & Daimon, T. (2020). A Bayesian basket trial design that borrows information across strata based on the similarity between the posterior distributions of the response probability. Biometrical Journal, 62(2), 330-338.

Examples

design_fujikawa <- setup_fujikawa(k = 3, p0 = 0.2)

Setup Global JSD Design Object

Description

Setup Global JSD Design Object

Usage

setup_jsdglobal(k, p0, shape1 = 1, shape2 = 1)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

shape1

First common shape parameter of the beta prior.

shape2

Second common shape parameter of the beta prior.

Details

The class jsdglobal implements a version of the power prior design, in which information is shared based on pairwise similarity and overall heterogeneity between baskets. Both pairwise similarity and overall heterogeneity are assessed using the Jensen-Shannon divergence.

Value

An S3 object of class jsdglobal

References

Baumann, L., Sauer, L., & Kieser, M. (2024). A basket trial design based on power priors. arXiv:2309.06988.

Examples

design_jsdglobal <- setup_jsdglobal(k = 3, p0 = 0.2)

Setup mml Design Object

Description

Creates an object of class mml.

Usage

setup_mml(k, p0, shape1 = 1, shape2 = 1)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

shape1

First common shape parameter of the beta prior.

shape2

Second common shape parameter of the beta prior.

Details

The class mml implements a modified version of the empirical Bayes method by Gravestock & Held (2017) which was proposed for borrowing strength from an external study. In their approach, the sharing weight is found as the maximum of the marginal likelihood of the weight, given the external data set. This leads, however, to non-symmetric weights when applied to sharing in basket trials, i.e. Basket i would not share the information from Basket j as the other way round. Therefore, a symmetrised version is used, where the mean of the two weights resulting from sharing in both directions is used.

Value

An S3 object of class mml

References

Gravestock, I., & Held, L. (2017). Adaptive power priors with empirical Bayes for clinical trials. Pharmaceutical statistics, 16(5), 349-360.

Examples

design_mml <- setup_mml(k = 3, p0 = 0.2)

Setup mmlglobal Design Object

Description

Creates an object of class mmlglobal.

Usage

setup_mmlglobal(k, p0, shape1 = 1, shape2 = 1)

Arguments

k

The number of baskets.

p0

A common probability under the null hypothesis.

shape1

First common shape parameter of the beta prior.

shape2

Second common shape parameter of the beta prior.

Details

The class mmlglobal implements an empirical Bayes method by Gravestock & Held (2019) which was proposed for borrowing strength from multiple external studies.

Value

An S3 object of class mmlglobal

References

Gravestock, I., & Held, L. (2019). Power priors based on multiple historical studies for binary outcomes. Biometrical Journal, 61(5), 1201-1218.

Baumann, L., Sauer, L., & Kieser, M. (2024). A basket trial design based on power priors. arXiv:2309.06988.

Examples

design_mmlglobal <- setup_mmlglobal(k = 3, p0 = 0.2)

Calculate the Type 1 Error Rate for a Basket Trial Design

Description

Calculate the Type 1 Error Rate for a Basket Trial Design

Usage

toer(
  design,
  n,
  p1 = NULL,
  lambda,
  design_params = list(),
  iter = 1000,
  data = NULL,
  ...
)

Arguments

design

An object created with one of the setup functions.

n

The sample size per basket.

p1

Probabilities under the alternative hypothesis. If NULL then the type 1 error rate under the global null hypothesis is calculated.

lambda

The posterior probability threshold.

design_params

A list of params that is specific to the class of design.

iter

The number of iterations in the simulation. Is ignored if data is specified.

data

A data matrix with k column with the number of responses for each basket. Has to be generated with get_data. If data is used, then iter is ignored.

...

Further arguments.

Value

A numeric value.

Examples

# Example for a basket trial with Fujikawa's Design
design <- setup_fujikawa(k = 3, p0 = 0.2)
toer(design = design, n = 20, p1 = c(0.2, 0.5, 0.5), lambda = 0.95,
  design_params = list(epsilon = 2, tau = 0), iter = 1000)