The R Validation Hub is an R Consortium Working Group. The R Consortium supports several related working groups. These working groups have a similar overall objective (to support the use of R within the biopharmaceutical industry) but the working groups are complementary: each has its own distinct deliverables; and many of the R Validation Hub’s members are also members of the other working groups.
Submission Focussed Working Groups
R Tables for Regulatory Submission (RTRS) Working Group
Once results have been generated, they are typically formatted and sent to medical writing teams to include within a Clinical Study Report. The goal of the R Tables for Regulatory Submission (RTRS) working group is to create standards for creating tables that meet the requirements of FDA submission documents, and hence enhance the suitability of R for FDA submissions.
Submissions Working Group
The final step in the data journey is to package up the results in order to share with health authorities. The pharmaceutical submission process includes various IT and platform challenges which are the focus of the Submissions Working Group.
The R Validation Hub was started by the PSI AIMS Special Interest Group. However, support for the initiative grew rapidly following the inaugural R/Pharma Conference in Cambridge, Boston area. The R/Pharma Conference continues to grow in popularity and serves as a breeding ground for new ideas an initiatives relating to R.
The R/Medicine conference is also growing in popularity with a strong participation from R Validation Hub participants.
Clinical Statistical Reporting in a Multilingual World
A Phuse initiative called, ‘Clinical Statistical Reporting in a Multilingual World’ started in 2020. As with the R Consortium initiatives, this Phuse initiative maintains a close connection with the R Validation Hub. As they put it on their GitHub page, “Subtle differences exist between the fundamental approaches implemented by each language, yielding differences in results which are each correct in their own right.” One of the specific aims of this initiative is to “provide a framework for assessing the fundamental differences for a particular statistical analysis across languages”.
R Package Validation Framework
The R Validation Hub is focused on assessing and managing risk for public R packages. The Phuse R Package Validation Framework is targeted at those developing packages. The initiative aims to deliver a white paper and R package. As described in the project scope:
- “The White Paper will serve as a reference for industry on how to perform validation for user-contributed extensions of programming software. It will detail the elements that need to be met for the extension to be validated, and ways to document the process in a reusable, efficient, and sharable fashion.”
- “The R package will be developed to provide the tools and guidance for validating an R package. It will show how to take advantage of the tools that exist in the R language, and it will be based on the White Paper to ensure the baseline requirements are achieved”
The R Validation Hub was started by the Application and Implementation of Methodologies in Statistics (AIMS) Special Interest Group (SIG) within PSI. Supporting the R Validation Hub is one of the SIG’s stated objectives along with bridging the gap to SAS and educating members in R more broadly.