Virtual useR! 2024

In recent years, statisticians and analysts from pharma industry and regulatory agencies have increased adoption of open-source software such as R. R brings great benefits by providing a wealth of cutting-edge statistical tools, extension packages for interactive dashboard and documentation as well as adaptability to the latest data science trends. However, publicly available drug submissions with the R language as the core analysis language has been lacking and limits wider adoption within the Pharma industry. The R Consortium R Submission Work Group seeks to test the concept that a R-based language submission language can be bundled into a submission package and transferred successfully to FDA reviewers. As of May 2024, the R consortium R submissions working group has successfully completed three pilot submissions and received FDA CDER response letters. To our knowledge, these are the first publicly available submission packages that include components of open-source languages. In this talk, I will introduce the R consortium R submission Working Group and the completed Pilot 1, 2 and 3 findings, issues that we encountered, learnings as well as current work being done in Pilot 4.