7:00- 7:30 PM – The Journey to a Successful Shiny Application Submission to FDA

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. After a successful pilot of an R-based clinical analysis submission package, the R Consortium R Submissions Working Group launched a second pilot in 2022 to test whether a Shiny application created with R could be assembled into a submission package and successfully transferred to FDA reviewers. In this talk, I will share the development journey of the Shiny application with key highlights of open-source collaboration, novel tooling in the Shiny ecosystem, challenges in the overall process, and the key milestones that led to a successful submission to the FDA. This project has the potential of becoming the first key reference of using Shiny in a regulatory context, paving the way for new innovations in how the life sciences industry can leverage R in new and innovative ways as part of clinical submissions.