Affiliates
There are a lot of related initiatives in the R infrastructure & cross-pharma space aiming to deliver open solutions to health authority engagement.
This document aims to outline some of these intiatives and help to outline the overlap and differences between initiatives:
R Consortium
The central mission of the R Consortium is to work with and provide support to the R Foundation and to the key organizations developing, maintaining, distributing and using R software through the identification, development and implementation of infrastructure projects.
The R Consortium sponsors many working groups, such as the R Validation Hub. The R Consortium represents general R community interests, which includes supporting adoption of R in industry.
Noteable initiatives sponsored by the R Consortium that will be helpful partners to help us tackle regulatory-ready package assessment and/or distribution include:
R Validation Hub
The main challenge of using R in late-phase trials is ensuring validation documentation. In June 2018, the R-Consortium awarded funding to create an online repository for R package validation in accordance with regulatory standards.
R Validation Hub is a collaboration to support the adoption of R within a biopharmaceutical regulatory setting
The R Validation Hub is our parent organization. We are one of multiple initiatives that each support the grand vision of streamlining the use of R in a regulated setting.
In the past this has involved endorsing a white paper that details how R might be used in a regulated setting, building tools to support individual R package evaluation, and offering an open forum for companies to share their approaches.
To further support this, the next phase of the R Validation Hub initiatives have been focused on lifting these activities out of individual organizations and into an open, shared context. This is where we come in!
pharmaverse
A curated, opinionated, pharma stack of open source R packages to enable clinical reporting (from CRF to eSubmission) backed by a community of passionate individuals and organisations committed to co-creating efficiency in our mission to improve health.
In other words, a set of R packages to achieve common submission workflows. Although these packages intend to meet a level of quality that would make them suitable for developing submission analysis.
Submissions Working Group
The R submission working group is a cross industry pharma working group focusing on improving practices of R-based clinical trial regulatory submission.
The submissions working group has fostered close ties to health authority representatives and runs periodic pilots to solicit feedback from health authorities regarding focused R submission concerns in an open setting.
In the past this has included such topics as:
How to submit R packages, which rely on directory structures and file extensions not currently supported through the FDA’s electronic submissions platform.
Feedback on Shiny-based analysis dashboards as a resource for submission review
In the future, the Submissions Working Group might be a valuable resource to deliver questions to health authorities regarding the usefulness of planned deliverables.
R Repositories Working Group
The goal of this working group is to collaboratively explore how to support, maintain, and improve the tooling for package distribution, particularly with an eye to meeting new needs (e.g. the demands of regulated submission as experienced by the pharma community) and making sure R is well poised to thrive for the next 20 years.
The R Repositories Working Group has been focused on understanding the CRAN checks with the goal of improving transparency. Their remit includes shaping the R ecosystem to support spaces such as the pharma community, which makes them a key partner.
More discussion is needed to understand whether this group intends to develop infrastructure outside of CRAN. Wether on CRAN or not, If so, it will be our responsibility to articulate the regulatory requirements that need to be met to make such a repository actionalbe for regulatory use.