What is {cardinal}?
The {cardinal} initiative is an industry collaborative effort under pharmaverse that unites Boehringer Ingelheim, Moderna, Roche, and Sanofi with the aspiration of building and open-sourcing a comprehensive catalog of harmonized tables, listings, and graphs (TLGs) for clinical study reporting. By leveraging existing open-source R packages, {cardinal} aims to simplify the process of output review, comparison, and meta-analyses, while fostering efficient communication among stakeholders in the pharmaceutical industry.
Why do we build it?
The collaborative effort focuses on improving the clarity, consistency, and accessibility of TLGs by addressing variations and redundancies in their creation and use. This harmonized approach allows for streamlined reporting processes and facilitates effective communication of study results within the industry and to regulatory authorities.
What has been done so far?
Drawing inspiration from the FDA Standard Safety Tables and Figures Integrated Guide, the {cardinal} initiative has successfully developed and open-sourced 11 templates to date. 4 product owners and 11 developers from 4 companies have collaborated to make these templates available and also published them on the official {cardinal} website.
Next steps & vision
Future plans for {cardinal} involve expanding the catalog through continuous collaboration from participating companies and inviting wider industry engagement. The ultimate goal is to promote harmonization of TLGs for clinical reporting across the pharmaceutical industry, leading to greater efficiency, collaboration, and innovation. Even though templates currently come from a published FDA guide, the collaborating companies are open to share and discuss similarities and differences on analysis concepts and output layouts of their own implementations in clinical reporting, for both safety and efficacy analyses.
In addition, while currently all templates were built using {rtables}, {tern}, {rlistings} and drew inspiration from the open-sourced TLG-Catalog, moving forward, we plan to support creating the same templates using alternative table engines such as {gt}.
{cardinal} will be presented at the upcoming PHUSE EU (Standards Implementation stream), where we will share the collaboration journey of {cardinal} so far, providing more details on the current progress, long-term vision, and strategies for this initiative. Attendees will gain insights into the challenges and opportunities of harmonizing clinical reporting through open-source collaboration and learn about the potential benefits and future direction of {cardinal}.
Last updated
2024-11-15 19:41:02.667917
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BibTeX citation:
@online{shen2023,
author = {Shen, Vincent},
title = {Cardinal},
date = {2023-07-09},
url = {https://pharmaverse.github.io/blog/posts/2023-07-09_cardinal/falcon.html},
langid = {en}
}
For attribution, please cite this work as:
Shen, Vincent. 2023. “Cardinal.” July 9, 2023. https://pharmaverse.github.io/blog/posts/2023-07-09_cardinal/falcon.html.