NEWS.md

In RConsortium/submissions-pilot2: R Consortium R Submission Pilot 2

pilot2wrappers 0.10.0

• Add usage guide for application (#61)
• Remove treatment variables from the adtte set prior to generating filters in KM plot module (#60).
• Ensure data filters within the KM-Plot module are only applied to data sets inside that module, and not on the remaining modules (#59).
• Ensure inference p-values are still displayed within primary and efficacy tables after applying filters in KM-Plot module.
• Add specific notes regarding filter usage and overlapping variables inside the KM module per user feedback.
• Display a message to the user when filtered data does not contain enough observations for survival probabilities and confidence intervals in the KM-Plot module. A note in the ADRG has also been added for this situation.
• Add note in ADRG regarding warning messages when restoring the teal and teal.data packages after the renv package library completes installation.
• Correct typos in ADRG Quarto document.

pilot2wrappers 0.9.0

• Fix RMSE calculation in efficacy table to match result in Pilot 1

pilot2wrappers 0.8.0

• Switch to adlbc as source for visit completion to remain consistent with efficacy analysis
• Fix incorrect sample sizes for baseline visit in primary analysis table
• Fix misc typos for ADRG

pilot2wrappers 0.7.0

• Include analysis model specification as a footnote in the efficacy table (#55)
• Add new frequency table of visit completion by treatment group (#53)
• Revise title for efficacy table (#52)
• Fix incorrect header order for primary table (#51)
• Ensure decimal places for rounding numeric results in demographics table is consistent with Pilot 1 programming (#54)

pilot2wrappers 0.6.0

• Remove Teal filters for every module except KM-plot to address FDA reviewer feedback
• Increase risk table and plot label font sizes
• Add bootstrap alert box with subgroup disclaimer in KM-plot module

pilot2wrappers 0.5.0

• Hide p-values when a data filter is applied, and display only when no filters are applied. This addresses comments from FDA reviewers after they saw a preview of the application.
• Add a new description in the App Information module regarding display of p-values.
• Add another footnote to the primary and efficacy table displays regarding the p-value display.
• Increase plot window height for KM module, improving readability

pilot2wrappers 0.4.0

• Ensure column width of efficacy table's 95% CI header is wide enough to fit in a single row
• Add missing footnotes to primary table
• Add new vignettes for ADRG as a Quarto document (with HTML and PDF output) and cover letter as a R-Markdown document using the {pagedown} package.

pilot2wrappers 0.3.0

• Enable support for using {pkglite} to create package bundle compliant with ECTD submission transfer standards
• Fix display of tooltips in select modules by using the {tippy} R package
• Add helper function set_data_path for the user to set the directory path to .xpt data files loaded into the application

pilot2wrappers 0.2.0

• Convert Shiny application to a package structure using {golem}.
• Incorporate the open-source {teal} package inside application to provide dynamic filters in all modules

pilot2wrappers 0.1.0

• Initial version.
• Added a NEWS.md file to track changes to the package.

RConsortium/submissions-pilot2 documentation built on Feb. 7, 2025, 1:24 a.m.