gsDesign2 1.1.0

Breaking changes

• Split fixed_design() into a group of fixed_design_*() functions for enhanced modularity (#263).
• gs_design_rd() and gs_power_rd() now have updated options of weighting for stratified design (#276).
• ppwe() now accepts two arguments duration and rate instead of a data frame fail_rate (#254).
• Unexport helper functions gridpts(), h1(), and hupdate() (#253).

New features

• Introduce define_enroll_rate() and define_fail_rate() as new input constructor functions to replace the tibble inputs (#238).
• Add a new function pw_info() which calculates the statistical information under the piecewise model (#262).

Improvements

• Add a vignette showing the canonical joint distribution of Z-score and B-values under null and alternative hypothesis for the AHR test (#246).
• Refactor expected_event() to improve computational performance (@jdblischak, #250).
• Move the source code of the legacy version from inst/ to tests/testthat/ as developer tests (#269).

gsDesign2 1.0.9

Improvements

• Add CRAN download counts badge (#215).
• Update documentation of gs_design_rd() (#220).
• Format footnote numbers using decimal notation (#222).
• Split C++ functions into individual cpp and header files (#224).

Bug fixes

• Fix the digits display in summary() (#231).

gsDesign2 1.0.8

Improvements

• Update the calculation of upper/lower bounds at the final analysis in MaxCombo tests (#217).
• Update the fixed_design() function in the application of stratified design when using the Lachin and Foulkes method (#211).
• Correct the fixed_design() function in the application of rmst (#212).
• Rename the info_scale argument options from c(0, 1, 2) to c("h0_h1_info", "h0_info", "h1_info") to be more informative and make the default value ("h0_h1_info") clear (#203).
• Add missing global functions/variables (#213).
• Fix outdated argument names and use canonical style for text elements in README (#198).
• Add a CRAN downloads badge to the readme to show the monthly downloads (#216).

Bug fixes

• Fix the calculation of the futility bounds in gs_power_ahr() (#202).

gsDesign2 1.0.7

Improvements

• Move imported dependencies from Suggests to Imports.
• Remove redundant dependencies from Suggests.
• Update the GitHub Actions workflows to their latest versions from upstream.
• Add a rule to .gitattributes for GitHub Linguist to keep the repository’s language statistics accurate.

gsDesign2 1.0.6

Improvements

• Export functions gridpts(), h1(), hupdate(), and gs_create_arm() to avoid the use of ::: in code examples.
• Fix the write path issue by moving the test fixture generation script to data-raw/ which is not included in the package.

gsDesign2 1.0.5

First submission to CRAN in March 2023.

Breaking changes

• Passes lintr check for the entire package (#150, #151, #171).
• Improve the documentation (#161, #163, #168, #176).

Bug fixes

• check_fail_rate() when only 1 number in fail_rate is > 0 (#132).
• gs_power_ahr() when study duration is > 48 months (#141).
• fixed_design() for event-based design (#143).
• gs_design_combo() when test only applies to part of the analysis (#148).
• gs_info_rd() for variance calculation (#153).
• summary() for capitalized first letter in the summary header (#164).

gsDesign2 1.0.0

GitHub release in December 2022.

Breaking changes

• Merges gsDesign2 v0.2.1 and gsdmvn.
• Updates API to follow the new style guide in vignette("style"). See the detailed mapping between the old API and new API in #84.

New features

• Supports organized summary tables and gt tables.
• Power/sample size calculation for risk difference.
• Integer sample size support (#116, #125).
• Adds fixed_design() to implement different methods for power/sample size calculation.
• Adds info_scale arguments to gs_design_*() and gs_power_*().
• Adds RMST and milestone methods to fixed design.

Bug fixes

• expected_accrual() for stratified population.
• gs_spending_bound() when IA is close to FA (#40).
• gs_power_bound() when applied in the MaxCombo test (#62).
• gs_design_npe() for type I error (#59).

Minor improvements

• Adds and re-organizes vignettes.

gsDesign2 0.2.1

GitHub release in August 2022.

• The release before merging with Merck/gsdmvn.

gsDesign2 0.2.0

GitHub release in May 2022.

• Supports the Biometrical Journal paper “A unified framework for weighted parametric group sequential design” by Keaven M. Anderson, Zifang Guo, Jing Zhao, and Linda Z. Sun.

gsDesign2 0.1.0

GitHub release in May 2021.

• Updated AHR vignette to introduce average hazard ratio concept properly.
• Added arbitrary distribution vignette to demonstrate s2pwe().
• Corrected calculations in AHR() when using stratified population.
• Release for Regulatory/Industry Symposium training.

gsDesign2 0.0.0.9006

GitHub release in December 2019.

• Added vignette for eEvents_df() explaining the methods thoroughly.
• Updated eEvents_df() to simplify output under option simple = FALSE.

gsDesign2 0.0.0.9005

GitHub release in December 2019.

• Updated docs/ directory to correct the reference materials on the website.
• Minor fixes in eAccrual().

gsDesign2 0.0.0.9004

GitHub release in November 2019.

• Moved new simulation functions to the simtrial package (simfix(), simfix2simPWSurv(), pMaxCombo()).

gsDesign2 0.0.0.9003

GitHub release in November 2019.

• Tried to make AHR() and simfix() more compatible with each other.
• Improved vignette for group sequential design.
• Added pkgdown website for documentation and vignettes.
• Added support functions for to support approximation using and visualization of the piecewise model.

gsDesign2 0.0.0.2

GitHub release in October 2019.

• Update AHR() to output trial duration, expected events and average hazard ratio in a tibble.
• Vignette AHRvignette demonstrating sample size computations for fixed design under non-proportional hazards assumptions.
• Vignette gsNPH demonstrating sample size computations for group sequential design under non-proportional hazards assumptions.
• Initial implementation of pMaxCombo() to compute p-value for MaxCombo test; pMaxComboVignette demonstrates this capability.

gsDesign2 0.0.0.1

GitHub release in September 2019.

• Computations based on piecewise constant enrollment and piecewise exponential failure rate.
• Expected event count calculation for each different hazard ratios in eEvents_df().
• Average hazard ratio computation based on expected event counts in AHR().
• Vignette demonstrating fixed sample size computation with simulation to verify power.