The Year Ahead

Doug Kelkhoff, on behalf of the R Validation Hub


R/Pharma Virtual 2024, October 29th

Slides available: pharmar.github.io/events-rpharma-virtual-2024

👋 Who We Are

The R Validation Hub is a collaboration to support the adoption of R within a biopharmaceutical regulatory setting (pharmaR.org)

  • Grew out of R/Pharma 2018
  • Led by participants from ~10 organizations
  • With frequent involvement from health authorities (primarily the FDA)
  • And subscribers from ~60 organizations spanning multiple industries

🤝 Affiliates:

Works with and provides support to the R Foundation and to the key organizations developing, maintaining, distributing and using R software

Key Pharma Activities

  • The R Validation Hub
  • R Submission Working Group
  • R/Medicine
  • R-Hub
  • R Repositories Working Group (ie CRAN enhancements, future development)

Impact

Community Grants & Sponsorships

Over USD $1.4 Million

Organizing Large Scale Collaborative Projects

R Validation Hub, R-Ladies

Co-Host Multidisciplinary Data Science Forums

Stanford Data Institute

Direct Support for Key R Events

R/Medicine, R/Pharma, useR!, LatinR, and more

Direct Worldwide Support for R User Groups

Join the R Consortium

r-consortium.org

  • Help guide the future direction of the R language
  • Collaborate on cross industry initiatives
  • Raise your leadership profile in the R Community
  • Protect your investment in R while supporting the common good

👷‍♂️ The R Validation Hub: What We Do

Products

White Paper

Guidance on compliant use of R and management of packages

Repositories

Building a public, validation-ready resource for R packages

Coline Zeballos

Communications

Connecting validation experts across the industry

Jaxon Abercrombie, Anuja Das, Antal Martinecz

{riskmetric}

Gather and report on risk heuristics to support validation decision-making

Eric Milliman

{riskassessment}

A web interface to {riskmetric}, supporting review, annotation and cataloging of decisions

Aaron Clark, Jeff Thompson

{riskscore}

An R data package capturing risk metrics across all of CRAN

Aaron Clark

Reflecting on our Tools

Evolving Interests

This year marks a turning point for riskmetric


🌱 How it started

  • A tool to support advocacy of the use of R
  • Prefer simplicity of reasonable indications of quality with minimal knowledge of ecosystem
  • Primary user story was for data scientists to build a case for what good software looks like

🌳 How it’s going

  • A tool to support administration of R packages
  • Prefer precise indicators of quality, with full awareness of complexity of ecosystem
  • Primary user story is now to build a production-grade R environment

Accumulation of Features

riskmetric

  • 😁 Quantifies R packages

riskassessment

  • 😁 Shiny app around riskmetric

Regulatory Repos

  • 😁 Serve repo with riskmetrics

Accumulation of Features

riskmetric

  • 😁 Quantifies R packages
  • 🤔 Scoring R packages

riskassessment

  • 😁 Shiny app around riskmetric
  • 🤔 Customizing package scoring criteria

Regulatory Repos

  • 😁 Serve repo with riskmetrics
  • 🤔 Customizing package filters

Accumulation of Features

riskmetric

  • 😁 Quantifies R packages
  • 🤔 Scoring R packages
  • 😬 Perceived industry standard

riskassessment

  • 😁 Shiny app around riskmetric
  • 🤔 Customizing package scoring criteria
  • 😬 Report generation

Regulatory Repos

  • 😁 Serve repo with riskmetrics
  • 🤔 Customizing package filters
  • 😬 Report generation

Accumulation of Features

🚀

Each team pushing forward to bring new features

🫱🏽‍🫲🏿

Recognizing commonality across new capabilities

🧩

Expose opportunities for dedicated teams and more unified vision

Toward more Intentional Scopes

Toward more Intentional Scopes

Toward more Intentional Scopes

Toward more Intentional Scopes

Governance

  • Industry scoring recommendations
  • Involve more regulatory expertise

Decision Tools

  • Simple syntax for specifying criteria
  • Easily interpretable by regulators

Reporting

  • Off-the-shelf regulatory templates
  • Consitent reporting across tools

Thank You

We look forward to hearing more from you at our Developer Day