A Pivotal Year of R Pilots for Shiny Application Submissions to the FDA / Celebrating a Milestone: R Tables for Regulatory Submission Working Group s eBook on Clinical Data Table Generation


Within the life sciences industry, Shiny has enabled tremendous innovations to produce web interfaces as frontends to sophisticated analyses, dynamic visualizations, and automation of clinical reporting across drug development. While industry sponsors have widely adopted Shiny as part of their analytics and reporting toolset, a relatively unexplored frontier has been the inclusion of a Shiny application inside a clinical submission package to regulatory agencies such as the FDA. The R Consortium R Submissions Working Group has continued the positive momentum of previous submission pilots to achieve substantial progress in this domain. In this talk, we will share the development journey of the working group’s Pilot 2 successful submission of a Shiny application to the FDA, along with the progress on the use of novel technologies such as Linux containers and web assembly to bundle a Shiny application into a self-contained package, facilitating a smoother process of both transferring and executing the application. The R Consortium’s R Tables for Regulatory Submissions (RTRS) Working Group has released the first edition of (Tables in Clinical Trials with R)[ https//rconsortium.github.io/rtrs-wg/] as a free and openly accessible ebook. The book contributes to the development of a theory of displaying tabular information by identifying a small number of table archetypes that may be used to generate the most common tables employed in clinical submissions. Chapters in the book demonstrate how these tables may be rendered in different R Packages including flextable, gt, rtables (with and without tern), tables, tfrmt and tidytlg. All tables are generated from CDISC-compliant data. Comparing the code showcases the robustness of R for aggregating and displaying tabular information and illuminates the flexibility and design tradeoff of the various R packages. The talk will discuss the motivation for the book, present the idea of table archetypes, show some representative tables, and make the case for R as a superb language for analyzing clinical trial data. The RTRS working group expects Tables in Clinical Trials with R to become a primary resource of clinical programming teams.

Presented at 2023 Conference