Supercharging Statistical Analysis with ARDs and the {cards} R Package
Enhancing Automation, Traceability, and Reliability in Your Statistical Workflow.
🗓️ Thursday June 12, 2025 | 1:01 - 1:21PM EDT
🏢 Virtual Conference
💥 FREE for R/medicine 2025 Attendees!
-> Youtube Video
Abstract
We present a pioneering application of the Analysis Results Dataset (ARD) framework for preparing clinical trial readouts. By leveraging open-source R packages, we demonstrate a streamlined and reproducible approach to generate comprehensive trial results. Our experience preparing a health authority filing highlights the consequences of non-standard Analysis Results readouts and storage. The newly released {cards} package developed by Roche, GSK, Novartis, Pfizer, and Eli Lilly builds ARDs, which can be seamlessly and robustly converted into visually appealing tables, utilizing the {gtsummary} package. The recent integration of ARD functionality into {gtsummary} (the most popular package for summary tables in the R ecosystem), marks a significant advancement for pharmaceutical companies. This integration underscores the growing importance of ARD as a standardized format for representing statistical analysis results, including improved automation, reproducibility, reusability, and traceability. We believe that this approach will become increasingly essential for ensuring the quality and efficiency of clinical trial reporting.
Very Useful resources:
Collaboration framework Pharmaverse: https://pharmaverse.org/
{cards} website: https://insightsengineering.github.io/cards/latest-tag/
Amazing PHUSE25 workshop: https://www.danieldsjoberg.com/ARD-PHUSE-workshop-2025/
Slides
Biography
Becca Krouse is a data scientist in GSK’s Statistics and Data Science Innovation Hub. A biostatistician by training, she has experience spanning 14+ years in the field of clinical research and specializes in developing R-based tools.
Davide Garolini (he/his) is a Statistical Engineer with an M.Phys. in Biophysics and a Ph.D. in Computational Neuroscience, has over ten years of R programming and package development expertise, specializing in clinical data analysis and regulatory deliveries. He significantly contributes by improving key tools like {rtables}, {tern}, and {gtsummary} for regulatory compliance. Davide strongly advocates for open-source collaboration, promoting advancements in clinical research.