ARD-based Reporting in R with {cards} and {gtsummary} packages
🗓️ Tuesday June24, 2025 | 08:00 - 09:30AM PDT
🏢 CDISC COSA Spotlight Q2 2025
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Abstract
We present a pioneering application of the Analysis Results Dataset (ARD) framework for preparing a clinical trial readout. By leveraging open-source R packages, we have demonstrated a streamlined and reproducible approach to generating comprehensive trial results. The newly released {cards} package developed by Roche, GSK, and Novartis builds ARDs, which can be seamlessly and robustly be 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. Our experience preparing a health authority filing highlights the benefits of using ARDs, 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.
Slides
Biography
Daniel D. Sjoberg (he/him) is a Senior Principal Data Scientist at Genentech. Previously, he was a Lead Data Science Manager at the Prostate Cancer Clinical Trials Consortium, and a Senior Biostatistician at Memorial Sloan Kettering Cancer Center in New York City. He enjoys R package development, creating many packages available on CRAN, R-Universe, and GitHub. He is a co-organizer of rainbowR (a community that supports, promotes and connects LGBTQ+ people who code in the R language) and of the R Medicine Conference. Daniel is the winner of the 2021 American Statistical Association (ASA) Innovation in Statistical Programming and Analytics award and the Posit 2024 Pharma Table contest.