The R Validation Hub recently had its community meeting after a brief hiatus. The team discussed announcements, common challenges, and brainstormed ideas for possible future projects through the R Validation Hub. Here are some highlights of their meeting. Stay tuned for the next monthly community meeting, dates to be announced!

Announcements

We have some announcements about R Val Hub leadership and structure! Doug Kelkhoff, Principal Data Scientist / Statistical Software Engineer at Roche, will be taking over the R Validation lead role from Andy Nicholls.

Doug Kelkhoff has been supporting the adoption of R in the pharmaceutical space for the past 6 years. During his time at Roche, he has pushed the adoption of R through pilot clinical trials, showcasing the benefits of using R by crafting internal tools and building services that embed the R Validation Hub’s guidance as part of our software development lifecycle. He is passionate about making the use of open source tools in a regulated setting a viable path not just for large pharmaceutical companies, but for lean startups and the public sector by addressing challenges through open initiatives. We welcome Doug as the new lead!

Andy Nicholls, Senior Director, Head of Data Science at GSK, has been the lead of the R Validation team for over four years. He has greatly contributed to the working group, including his work with the R Adoption Series, presenting eight recent case studies covering how the R Validation Hub guidance is being put into practice across many of our industry partners. These case studies covered building a Gxp framework with R: https://www.pharmar.org/casestudies/ 

Thank you, Andy, for the contributions and leadership you brought to the R Validation Hub!

Interested in supporting the R Validation Hub with its communication workstream? We need volunteers to help us with improving consistency with branding, communication channels, and year-long planning, contact us: https://www.pharmar.org/contact/

Call To Action for the Community

During the community meeting, the team had discussions about how people use the riskmetric package for their evaluation processes and what they deem as too high-risk scores. 

Continue the conversation and participate in this riskmetric survey: https://bit.ly/risk_survey

Other Topics Covered During the Discussion Rounds 

CDISC data should be the standard for add-on unit testing, a common repo from the R Validation Hub would be very welcome.

Finally, we discussed who reviews R packages, including what is the role of software engineers, statisticians, and clinical experts. Join us in the next meeting to share your thoughts! 

Check out the Meeting Slides

Additional Resources 

• R Validation website: https://www.pharmar.org/ 
• Github repo with contributions: https://github.com/pharmaR/case_studies

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