The Pharmaceutical industry is moving towards open-source tools with companies adopting R/Shiny to revolutionize their processes in clinical reporting, drug development, and translational research, among other areas.  One of the initiatives of this global effort focuses on improving the practices of R-based clinical trial regulatory submission. The “R Submission Working Group” is exploring the use of R/Shiny applications for regulatory agencies to interactively review the data and analysis, complementing the static and extensive documentation.  We are going to take a look at the {teal}-based Shiny application that is being used as a proof-of-concept in FDA pilots and present two formats for packaging the application that aims at allowing the reviewers to access the application seamlessly and without the overhead of setting a complex local R environment and installing all the packages and system dependencies.  The packaging formats include Podman, an open-source alternative to Docker, and webR, which allows R and Shiny to run exclusively in the browser without any system dependencies. webR is still under heavy development and it is an exciting opportunity that is made possible by the innovation of an open-source global community.
André Veríssimo
Appsilon
Exploring the Packaging of R / Shiny Applications for Regulatory Submission
The Pharmaceutical industry is moving towards open-source tools with companies adopting R/Shiny to revolutionize their processes in clinical reporting, drug development, and translational research, among other areas.  One of the initiatives of this global effort focuses on improving the practices of R-based clinical trial regulatory submission. The “R Submission Working Group” is exploring the use of R/Shiny applications for regulatory agencies to interactively review the data and analysis, complementing the static and extensive documentation.  We are going to take a look at the  teal -based Shiny application that is being used as a proof-of-concept in FDA pilots and present two formats for packaging the application that aims at allowing the reviewers to access the application seamlessly and without the overhead of setting a complex local R environment and installing all the packages and system dependencies.  The packaging formats include Podman, an open-source alternative to Docker, and webR, which allows R and Shiny to run exclusively in the browser without any system dependencies. webR is still under heavy development and it is an exciting opportunity that is made possible by the innovation of an open-source global community.