Using R to Submit Research to the FDA: Pilot 4 Successfully Submitted to FDA Center for Drug Evaluation and Research
The R Consortium is excited to announce that, on September 20, 2024, the R Submissions Working Group successfully submitted its latest test submission package—featuring a WebAssembly component—through the FDA’s Electronic Common Technical Document (eCTD) gateway! This marks a significant milestone as the FDA Center for Drug Evaluation and Research (CDER) staff has officially received the submission package.
Statistician Eric Nantz at pharmaceuticals company Eli Lilly in Indianapolis, Indiana, says that using WebAssembly “will minimize, from the reviewer’s perspective, many of the steps that they had to take to get the application running on their machines.”
The complete set of submission materials is available publicly on GitHub: R Consortium Submissions Pilot 4.
About the Pilot 4 Project
The objective of the R Consortium R submission Pilot 4 Project is to explore the use of novel technologies such as Linux containers and WebAssembly to bundle a Shiny application into a self-contained package, facilitating a smoother process of both transferring and executing the application. The application was built using the source data sets and analyses contained in the R submission Pilot 1-3. To our knowledge, this is the first publicly available submission package that includes a WebAssembly component. We hope this submission package and what we have learned can serve as a good reference for future regulatory submission efforts. The WebAssembly technology compiles applications into a portable, consistent environment driven by a web browser, allowing agency reviewers to easily run and evaluate software without complex setups. The second half of the Pilot 4 Project (leveraging container technology to package a Shiny application) will be submitted as an additional package later this year. Additional agency feedback will be shared in future communications.
About the R Submissions Working Group
The R Consortium R Submissions Working Group is focused on improving practices for R-based clinical trial regulatory submissions.
Health authority agencies from different countries require electronic submission of data, computer programs, and relevant documentation to bring an experimental clinical product to market. In the past, submissions have mainly been based on the SAS language.
In recent years, the use of open source languages, especially the R language, has become very popular in the pharmaceutical industry and research institutions. Although the health authorities accept submissions based on open source programming languages, sponsors may be hesitant to conduct submissions using open source languages due to a lack of working examples.
Therefore, the R Submissions Working Group aims to provide R-based submission examples and identify potential gaps while submitting these example packages. All materials, including submission examples and communications, are publicly available on the R consortium GitHub page.
Join the R Submissions Working Group
The R Submissions Working Group comprises members from over 10 pharmaceutical companies, as well as regulatory agencies. We are a collaborative community open to anyone interested in contributing to this important work. For more information, or to get involved, visitour website or contact us directly at director@r-consortium.org.