R-based Test Submission Package for FDA Evaluation: A Milestone in R-based Regulatory Submissions

This demo highlights the efforts led by Joel Laxamana, a statistical programmer at Genentech, to develop an R-based approach for submitting clinical trial packages to the FDA. Traditionally, sponsors have used proprietary tools like SAS, but there is growing interest in open source software like R. The R Consortium R submission Working Group is creating R-based submission packages to improve transparency and reproducibility in the approval process. Their initiatives include pilot projects using R scripts and a Shiny app for submissions. Main Sections 00:00 Introduction 04:11 The R Consortium R submission Working Group 04:57 Overview of Pilots 15:05 Open source language-based submissions to FDA & challenges 16:25 Pilot 3 Demonstration 56:08 Q&A More resources R Validation Hub Site: https://www.pharmar.org/ Main Site: https://www.r-consortium.org/ News: https://www.r-consortium.org/news Blog: https://www.r-consortium.org/news/blog Join: https://www.r-consortium.org/about/join Twitter: https://twitter.com/rconsortium?lang=en LinkedIn: https://www.linkedin.com/company/r-consortium Mastodon: https://fosstodon.org/@RConsortium