Study-Specific Assessment of R Package Risk at SCHARP

on April 30, 2026

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch Cancer Center is a statistical and data management center dedicated to supporting investigators who are leading life-saving, life-changing, innovative research to prevent HIV/AIDS and other infectious diseases. A team from SCHARP recently presented at the PHUSE US-Connect 2026 event hosted in March, detailing their experiences and processes associated with study-specific assessment of R package risk.

The team at SCHARP had historically contributed to regulatory submissions in SAS. However, with the strong preference for R in the HIV vaccine statistical community, it became important to build a rigorous framework for R validation to ensure software reliability and perform risk assessment. Using guidance from the R Validation Hub’s white paper and leveraging the {riskmetric} package, their framework is built around study-specific purpose, software development lifecycle, community usage, and testing. Given SCHARP’s limited resources, the framework is currently mandated only for high-profile trials and is further customized according to each trial’s risk appetite and with an intent to build broader risk assessment experience in their organization.

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{riskassessment} ShinyGatherings x Pharmaverse Workshop

on February 11, 2025

At a recent ShinyGatherings, some {riskassessment} contributors presented a workshop that focused on tailoring the application to org-specific risk requirements to simplify R package validation. Though we discussed the end-user experience, this workshop was really geared towards equipping “app deployers” to get the highest and best use out of the application for their organization’s specific needs. We appreciate Appsilon for the opportunity to speak about the application!

About the Workshop

The workshop’s main topics:

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Risk Assessment App v3.1.1

on August 8, 2024

Progress is continuing to be made in {riskassessment}. We wanted to share some of the enhancements and updates included in the most recent release of the application. There have been multiple releases, both minor and major, since our last post, so we have a lot of new content to cover!

But before we get into too much detail, if you are new to what we are doing in {riskassessment}, we would like to encourage you to check out our README. There you can find information regarding what {riskassessment} is seeking to accomplish and how you can install and deploy an instance of it for your personal or organizational use.

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Updates to the R Validation Hub Executive Team

on September 5, 2023

As the R Validation Hub closes in on its 5th year of activity I want to take a quick trip down memory lane and reflect on how we got here. Perhaps I should start by reminding everyone how it all started. Back in 2018, as the prospect of using R for any regulated analysis was still a hotly contested question, industry participants brought our donated space at Harvard to capacity as attendees gathered for the first ever R/Pharma conference. Amidst a slew of impressive shiny applications (I vividly remember shiny being the decided tone-setting theme that year), one Andy Nicholls offered up a deceptively simple question: what should validated use of R look like?

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