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BinGSD

The goal of BinGSD is to calculate boundaries and conditional power for single-arm group sequential test with binary endpoint. Two kinds of tests are available in this package: asymptotic test based on normal distribution; exact test based on binomial distribution. BinGSD also provides functions to compute boundary crossing probabilities given a specific design.

Installation

The released version of BinGSD can be downloaded from CRAN with:

install.packages("BinGSD")

Architecture

There are six functions in BinGSD to satisfy the needs of user to design and analyse the single-arm group-sequential trial with binary endpoints:

• asymdesign: compute sample size and boundaries for each analysis, under asymptotic test.
• exactdesign: compute sample size and boundaries for each analysis, under exact test.
• asymprob: given the design, compute boundary crossing probabilities under asymptotic test.
• exactprob: given the design, compute boundary crossing probabilities under exact test.
• asymcp: given the design and interim statistic, compute conditional power under asymptotic test.
• exactcp: given the design and interim statistic, compute conditional power under exact test.

Example

To design a single-arm group-sequential trial via BinGSD, user should first define some terms:

library(BinGSD) ##load package
I=c(0.2,0.4,0.6,0.8,1) ##information fractions
beta=0.2   ##desired overall type II error rate
betaspend=c(0.1,0.2,0.3,0.2,0.2) ##proportions of type II error spent at each analysis
alpha=0.05  ##desired overall type I error
p_0=0.3   #response rate under null hypothesis
p_1=0.5   #response rate under alternative hypothesis
K=5     #number of planned analyses
tol=1e-6 #tolerance level

Call function asymdesign to obtain sample sizes and boundaries based on asymptotic test, under the settings above:

asymdesign(I,beta,betaspend,alpha,p_0,p_1,K,tol) 

The output is an object of class asymdesign, including the last and only upper bound, lower boundaries, sample sizes, boundary crossing probabilities, actual overall type I error, power of the test, etc.

For usage of other functions in BinGSD, please refer to the manual or start with the examples at the last section of vignette.

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.