Recent years have seen a significant shift towards the adoption of open-source software like R by statisticians and analysts in both industry and regulatory agencies. This trend offers immense benefits, including cutting-edge statistical tools, interactive dashboard packages like Shiny, and adaptability to modern data science trends. Despite these advantages, the pharmaceutical industry's broader adoption of R for drug submissions has been limited. To address this, the R Consortium R Submissions Working Group (RCRSWG) aims to demonstrate that an R-based submission can be successfully reviewed by the FDA.

By May 2024, the RCRSWG completed three pilot submissions and received response letters from the FDA's Center for Drug Evaluation and Research (CDER), marking a significant milestone. These submissions are the first publicly available packages that use open-source languages.

This presentation will share highlights from May 2024, where three pilot submissions from RCRSWG were completed successfully with response letters from the FDA's Center for Drug Evaluation and Research (CDER), marking a significant milestone. These submissions are the first publicly available packages that use open-source languages. 

Additionally, we will provide an update on the ongoing work in Pilot 4 as well as explore the potential of R in regulatory submissions and the RCRSWG's efforts to improve R-based clinical trial submissions.


All materials are available on the R Consortium's GitHub page, showcasing our commitment to transparency and innovation in regulatory submissions.
Ben Straub | Joel Laxamana
GSK | Genentech
Piloting into the Future: Publicly Available R-based Submissions to the FDA
Recent years have seen a significant shift towards the adoption of open-source software like R by statisticians and analysts in both industry and regulatory agencies. This trend offers immense benefits, including cutting-edge statistical tools, interactive dashboard packages like Shiny, and adaptability to modern data science trends. Despite these advantages, the pharmaceutical industry's broader adoption of R for drug submissions has been limited. To address this, the R Consortium R Submissions Working Group (RCRSWG) aims to demonstrate that an R-based submission can be successfully reviewed by the FDA.  By May 2024, the RCRSWG completed three pilot submissions and received response letters from the FDA's Center for Drug Evaluation and Research (CDER), marking a significant milestone. These submissions are the first publicly available packages that use open-source languages.  This presentation will share highlights from May 2024, where three pilot submissions from RCRSWG were completed successfully with response letters from the FDA's Center for Drug Evaluation and Research (CDER), marking a significant milestone. These submissions are the first publicly available packages that use open-source languages.   Additionally, we will provide an update on the ongoing work in Pilot 4 as well as explore the potential of R in regulatory submissions and the RCRSWG's efforts to improve R-based clinical trial submissions.   All materials are available on the R Consortium's GitHub page, showcasing our commitment to transparency and innovation in regulatory submissions.