Bridging the Gap – Enhancing TFL Generation with CDISC ARS Model and Community TFL Library
29 January 2025
Description
PHUSE hosted this month’s Wednesday Webinar, featuring Bhavin Busa, Principal & Co-Founder of Clymb Clinical, as he presented his award-winning poster, "Bridging the Gap - Enhancing TFL Generation with CDISC ARS Model and Community TFL Library."
This session explored challenges in constructing TFL mock-up shells and the inefficiencies of manual processes in the clinical research industry. Bhavin shared insights from a survey of 253 participants on the need for standardized, machine-readable TFL shells and metadata, highlighting CDISC's Analysis Results Standard (ARS) as a key solution.
The presentation showcased the TFL Designer Community, a powerful tool for automating TFL generation using community templates and study-specific shells, designed to meet regulatory and industry standards.
Attendees gained a deeper understanding of how the ARS model and TFL Designer Community can transform TFL design and accelerate clinical workflows.
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Q&A
Can the CDISC ARS model support complex TFL programming, given that LinkML is the programming language used?
Yes, LinkML is used to create the components of the model, but the model itself is independent of the tool used to generate it.
Is the ARS model going to be released as a tool, or would it require LinkML programming by the end user?
The ARS model is already published on GitHub and is available for use. It does not require LinkML programming from the end user. LinkML was used to build a model. The model and associated examples can be consumed by the user in various different formats.
How will the eTFL Portal work with pharmaceutical companies, given that data will need to be uploaded? How do we ensure data privacy?
The eTFL Portal is hosted by CDISC and is not intended for direct data uploads by users. Instead, it provides reference examples and pre-built ARS-compliant TFL templates that organizations can use as a starting point for their studies.
Does the ARS model accommodate non-standard efficacy metadata?
Yes, the ARS model is designed to support non-standard efficacy metadata. While the initial examples focus on safety templates, CDISC plans to expand the eTFL Portal to include efficacy-related templates in collaboration with industry partners.
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