Abstract:

The CDISC Analysis Results Standard (ARS) Team is developing standards to improve and facilitate the automation, reproducibility, reusability, and traceability of analysis results (Tables, Figures and Listings, aka TFL). The team is working towards this objective by creating a logical model to incorporate the elements for both analysis results and associated metadata.

In this paper, we will provide a comprehensive overview of the CDISC Analysis Results logical model, including its background and development. We will discuss the current state workflow and challenges faced by analysts, as well as the future state envisioned with the introduction of the machine-readable analysis results metadata and analysis results data structure to automate the generation of statistical outputs and displays. We will describe the model's elements using examples to give a better understanding of the model itself and how it can improve traceability, reproducibility, and quality in clinical trial analysis and reporting.

Bhavin Busa is recognized as a thought leader in the areas of data standards, programming and regulatory submission. He is very passionate about leveraging standards and technology to expedite data review, analysis and submission processes. In line with his passion, Bhavin recently co-founded Clymb Clinical, a startup that is driving innovation and revolutionizing the clinical data industry through implementation of technology and open-source solutions. He devotes much of his time outside of his day job to volunteer with PHUSE and CDISC. He holds a position on the PHUSE Working Group Leadership Committee and serves on the CDISC Open-Source Alliance (COSA) Board. Additionally, Bhavin serves as a CDISC ARS Product Owner/Co-lead and is slated to be the Chair of upcoming PHUSE US Connect 2024.