https://github.com/rpodcast/opensub-ness2025
R-based Submissions talk at NESS 2025
https://github.com/rpodcast/opensub-ness2025
life-sciences r statistics
Last synced: about 1 month ago
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R-based Submissions talk at NESS 2025
- Host: GitHub
- URL: https://github.com/rpodcast/opensub-ness2025
- Owner: rpodcast
- Created: 2025-05-28T18:06:35.000Z (about 1 year ago)
- Default Branch: main
- Last Pushed: 2025-06-02T20:48:22.000Z (12 months ago)
- Last Synced: 2026-01-11T11:33:29.183Z (5 months ago)
- Topics: life-sciences, r, statistics
- Language: JavaScript
- Homepage: https://rpodcast.github.io/opensub-ness2025/
- Size: 42 MB
- Stars: 0
- Watchers: 0
- Forks: 0
- Open Issues: 0
-
Metadata Files:
- Readme: README.md
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README
## A Whole New (Open) World: Insights from R-based Submission Pilots
[Slides](https://rpodcast.github.io/opensub-ness2025/) for my talk at the 2025 [New England Statistics Symposium](https://symposium.nestat.org/) (NESS) Conference.
### Abstract
Within the life sciences industry, the R language 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 R 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. The R Consortium Submissions Working Group has continued the positive momentum of using R in clinical analyses by conducting pilot submissions which utilize public CDISC data sets in collaboration between talented scientists from pharmaceutical companies and submission reviewers from regulatory agencies such as the FDA. In this talk, I will share the development journey and key learnings from successful submissions of key deliverables such as TLFs, AdAM data sets, and Shiny applications in the Pilot submissions, along with the progress on the use of novel technologies such as Linux containers and web assembly to push the technical envelope further.
## Assorted References
* R/Pharma 2023 [slides](https://docs.google.com/presentation/d/1hQUqXAGcAlhwBXsDJ1D516N-fcN865qx/edit?slide=id.p1#slide=id.p1)
* Pilot 2 repository: https://github.com/RConsortium/submissions-pilot2
* Pilot 4 (container) repository: https://github.com/RConsortium/submissions-pilot4-container
* Pilot 4 (WebAssembly) repository: https://github.com/RConsortium/submissions-pilot4-webR
## Image credits
* Title slide image by [Greg Rakozy](https://unsplash.com/@grakozy) on [Unsplash](https://unsplash.com/photos/silhouette-photography-of-person-oMpAz-DN-9I)
* Race car image by [Maxime Agnelli](https://unsplash.com/@maxa) on [Unsplash](https://unsplash.com/photos/blue-and-white-f-1-car-on-road-arbAbFBQ2rw)
## Under the Hood
* Slides created with [Quarto](https://quarto.org)