1 of 13

Improving Efficiency and Reproducibility of Large-Scale Clinical Trials: Introducing the Analysis Results Standards

Anthony Chow

29 September 2023

2 of 13

Meet the Speaker

Anthony Chow

​

Title: Executive Director, Data Science

Organization: CDISC

​

Anthony Chow is a multi-faceted professional with a proven track record in developing international standards, implementing software, managing projects, and providing consultancy. His professional experience spans multiple industries over the 30 years of his career. He earned a degree in Computer Science and is currently pursuing his master’s in healthcare informatics. Anthony frequents professional conferences, volunteers, gives workshops, and presents on contemporary topics. In his free time, he enjoys nature photography and cooking for friends and family.

3 of 13

Agenda

  1. What Is CDISC?
  2. CDISC's Standards Related to Analysis
  3. Analysis Results Standards
  4. CDISC's Open-Source Initiative

4 of 13

What Is CDISC?

#ClearDataClearImpact

​

4

Nonprofit

standards development organization

Volunteers; consensus driven

Open access: PDF, Data Standards Browser, API

5 of 13

CDISC's Standards Related to Analysis

  • CDISC ADaM (Analysis Data Model)
  • Implementation Guides
  • Conformance Rules
  • ARM (Analysis Results Metadata)
  • ARS (Analysis Results Standards)

#ClearDataClearImpact

​

5

6 of 13

#ClearDataClearImpact

6

7 of 13

#ClearDataClearImpact

7

8 of 13

ARS Objectives

#ClearDataClearImpact

8

9 of 13

#ClearDataClearImpact

9

10 of 13

#ClearDataClearImpact

10

11 of 13

ARS Key Results

  • Model
  • GitHub repository
  • User Guide
  • Hackathon
  • Implementation examples

​

​

#ClearDataClearImpact

11

ARS Model Documentation

ARS User

Guide

12 of 13

CDISC Open-Source Alliance (COSA)

  • Provides a directory of open-source projects
  • Quarterly webinars & conference sessions
  • Hackathons & workshops
  • Open-source best practices & guidance
  • Collaborate with PHUSE and Pharmaverse
  • Community building
  • Promote open-source in regulated research
  • Directory: https://cosa.cdisc.org

12

COSA Mission: The CDISC Open-Source Alliance (COSA) supports, promotes, and sometimes sponsors open-source and free software development projects that create tools for implementing or developing CDISC standards to drive innovation in the CDISC community.

13 of 13

Thank You!