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Weighted parametric group sequential design (WPGSD) allows one to take advantage of the known correlation structure in constructing efficacy bounds to control family-wise error rate (FWER) for a group sequential design. Here correlation may be due to common observations in nested populations, due to common observations in overlapping populations, or due to common observations in the control arm.

Installation

The easiest way to get wpgsd is to install from CRAN:

Alternatively, to use a new feature or get a bug fix, you can install the development version of wpgsd from GitHub:

# install.packages("remotes")
remotes::install_github("Merck/wpgsd")

Current limitations

There are some limitations that are currently being addressed. Please use the package with caution in production environments.

  • The current implementation may have limitations when handling more complex scenarios beyond what has been demonstrated.
  • The API is subject to potential breaking changes as it is currently being reviewed and refactored.
  • Further validation is needed to ensure the reliability of the package.
  • More documentation is expected in the future releases.

References

Anderson, K. M., Guo, Z., Zhao, J., & Sun, L. Z. (2022). A unified framework for weighted parametric group sequential design. Biometrical Journal, 64(7), 1219–1239.

BibTeX entry:

@article{anderson2022unified,
  title     = {A unified framework for weighted parametric group sequential design},
  author    = {Anderson, Keaven M and Guo, Zifang and Zhao, Jing and Sun, Linda Z},
  journal   = {Biometrical Journal},
  volume    = {64},
  number    = {7},
  pages     = {1219--1239},
  year      = {2022},
  publisher = {Wiley Online Library}
}