This post was authored by Gregory Chen, Biostatistics and Research Decision Sciences (BARDS), MSD, Switzerland, and Ning Leng, Product Development Data Sciences (PDD), F. Hoffmann-La Roche, USA

On January 30, 2024, the R Consortium Submission Working Group made a presentation to Swissmedic in Bern, Switzerland, with 10 attendees in person and 50 online. It started with a motivation as to why to consider using open source and specifically R for regulatory submissions. The group then proceeded to show cases of the pilot 1 and 2 submission to FDA. 

The conclusion was an insightful discussion for about 20 minutes with the participants on the lessons learned, key factors to sort in line for broader adoption of R and Shiny for regulatory submissions, and what would be most added value for a regulatory shiny app, namely

1. How to deploy the submitted R package and Shiny App to guarantee the clinical outcomes can be smoothly reproduced on the regulatory side
2. What would be the ultimate purpose of a regulatory shiny app, and what are value-added features? Should the app only focus on offering interactivities to facilitate the review of tables, figures, and listings in CSR, or should it also include designed features to enable exploratory, descriptive analysis (e.g., for subgroups) to certain degrees, which may greatly shorten back-and-forth inquiry between regulator and drug developer?
3. Validation and version traceability of dependent open source R packages used in the submission package
4. How to leverage existing and emerging cross-industrial initiatives (e.g. R consortium) in the open source space to support and ease the potential technical issue during the adoption of R for submission

Accompanying this post, the full presentation slide deck is made publicly available here, inviting further exploration and discussion.

The R Consortium’s presentation at Swissmedic represents a hopeful step toward more interactive, efficient, and transparent regulatory submissions. As the conversation between the R Consortium and regulatory bodies continues, our future collection of pilot projects hopefully will offer richer examples and templates to our growing R community within the pharmaceutical sector, spanning both regulatory and drug developer sides.

To find out more about the R Consortium Submission Working Group, please see: https://rconsortium.github.io/submissions-wg/ 

The R Validation Hub next meeting is May 21st, 12:00 PM EST. 

Join the call here! 

In the dynamic field of pharmaceutical research, open source R packages offer incredible potential to innovate and enhance efficiency. The R Validation Hub is guiding the community building riskmetric and the riskassessment app. riskmetric is a framework to quantify an R package’s “risk of use” by assessing a number of meaningful metrics designed to evaluate package development best practices, code documentation, community engagement, and development sustainability. Together, the riskassessment app and the riskmetric package aim to provide some context for validation within regulated industries. 

The benefits of utilizing open source tools in pharmaceutical projects are compelling. To address these issues and maximize their potential, join us at the R Validation Hub community meeting on May 21st at 12:00 PM EST. This gathering will focus on sharing best practices, troubleshooting common problems, and exploring innovative solutions together.

Embrace the opportunity to transform pharmaceutical research with us. Let’s innovate, collaborate, and overcome these hurdles together.

Join the call here!

The R Consortium is rolling out its 2024 R User Groups (RUGS) Grant Program, and it’s an opportunity you don’t want to miss. The program, which aims to foster vibrant R communities worldwide, is in full swing, and we are eagerly awaiting your application!

Apply here!

Why Apply and… For What?

User Group Grants: Boost engagement and initiate user-focused activities.

Conference Grants: Support for R-related events, either hosting or attending.

Special Projects Grants: Kickstart innovative projects with the potential to impact the R community.

With 74 active groups and a thriving community of over 67,000 members, the RUGS network is a hub of innovation and knowledge sharing. Your participation could be the next milestone in this growth journey.

Examples of some recent R Consortium sponsored RUGS activities:

• The Cleveland R User Group’s Journey Through Pandemic Adaptations and Baseball Analytics
• R-Ladies Goiânia: Promoting Diversity and Inclusion in Local R Community

Key Information

Application Deadline: September 30th, 2024. Don’t delay!

Eligibility: Open to initiatives aimed at community building, not software development (for that, see ISC Grant Program).

Be part of shaping the future of R. Visit here for more details and to apply. Your contribution matters to the global R narrative. Apply now, and let’s grow together!

For details and to apply, visit here.

Help build R infrastructure! We’re opening the call for proposals for the 2024 Infrastructure Steering Committee (ISC) Grant Program. The R Consortium is dedicated to enriching the R Ecosystem, directly supporting projects that strengthen both its technical and social infrastructures.

Apply here!

What We Fund:

Our grants target projects that make a difference in the R community, focusing on:

Technical Infrastructure: Enhancements in key R packages, development tools like R-hub, and improvements for R on various operating systems.

Social Infrastructure: Projects like SatRDays that promote local engagement and initiatives for better tracking of R Consortium activities.

We’re eager to see your innovative ideas and how they can propel the R ecosystem forward. This is a call to action for all who wish to contribute to the growth and enhancement of R. Let’s build a stronger R community together!

Submit your proposal now and be a part of shaping the future of the R Ecosystem. Learn more about how to apply here.

We look forward to your submissions and furthering the R community’s advancement together!

Apply now!

Excerpted from the Annual Report

Access the annual report here!

Letter from the Chair — Mehar Pratap Singh, Chairman

Welcome to the 2023 Annual Report of the R Consortium. This document reflects a year of significant growth, innovation, and community engagement within and beyond the R ecosystem. As we present the accomplishments and milestones of the past year, we also set our sights forward, laying out the path for an even more collaborative and impactful future.  

The R Consortium serves as a central hub for the R community, bringing together industry leaders, academic institutions, and individual contributors to foster the development and proliferation of the R language. Our mission is to support the R community through funding, infrastructure improvement, community initiatives, and global outreach.  

In 2023, the R Consortium played a pivotal role in shaping the development of the R ecosystem. Through monetary grants, nearly $200,000 dollars to develop R packages and other technical infrastructure, through fostering industry wide collaborative working groups, and by supporting R-Ladies, R user groups, and several important industry conferences, including Latin-R, New York R, and Bioconductor conferences. This report highlights some of these achievements, showcasing the collective effort of our members and the broader community.  

Recognizing the dynamic nature of data science technologies and the evolving needs of industry, we also recognize the responsibility of the R Consortium to help set a vision for the evolution of the R ecosystem. As you read through this report, we hope you’ll appreciate the strides we’ve made together and feel inspired by the potential of what we can achieve in the future. The R Consortium is more than just an organization: it’s a vibrant community of innovators, problem-solvers, and thought leaders. Together, we are shaping a future where the power of R is accessible to all and continues to drive progress across industries worldwide.   

Thank you for your continued support and dedication to the R Consortium and the wider R community. 

Access the annual report here!

The R Consortium recently hosted a webinar series tailored specifically for insurance and actuarial science professionals. This series, called the R/Insurance webinar series, led by experts Georgios Bakoloukas and Benedikt Schamberger, was crafted to guide attendees from transitioning from Excel to R to implementing R in production environments, fostering a performance culture with R, and mastering high-performance programming techniques. 

Whether new to R or looking to deepen your expertise, these webinars offer valuable insights into leveraging R’s capabilities in your field. All sessions are now accessible on YouTube, providing a fantastic resource for ongoing learning and development. 

For further details and to watch the webinars, visit the R Consortium’s website.