All Times ET
Keywords: clinical trial, software
On Nov 22nd, 2021, the R Consortium R Submissions Working Group successfully submitted an R-based test submission package through the FDA eCTD gateway. The submission package has been received by the FDA staff who were able to reproduce the numerical results.
This submission was an example submission package following eCTD specifications which include a proprietary R package, R scripts for analysis, R-based analysis data reviewer guide, and other required eCTD components. To our knowledge, this is the first publicly available R-based FDA submission package. We hope this submission package and our learnings can serve as a good reference for future R-based regulatory submissions from different sponsors.
The R Consortium R Submissions Working Group is focused on improving practices for R-based clinical trial regulatory submissions.
To bring an experimental clinical product to market, electronic submission of data, computer programs, and relevant documentation is required by health authority agencies from different countries. In the past, submissions have been mainly 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 Consortium R Submissions Working Group aims at providing R-based submission examples and identifying potential gaps during submission of these example packages. All materials, including submission examples and communications, are publicly available on the R consortium Github page. All submission materials can be found at: https://github.com/RConsortium/submissions-pilot1-to-fda