1. Data Visualizations Working Group
Advancing clinical review through emerging technologies and trends in data graphics
March 20th, 2017

2. DV 2017 Focus Areas
Interactive visualizations for processes, reports, and clinical submissions
Emerging trends and innovative approaches to patient profiles
Collaboration with other PhUSE working groups, industry groups, and our FDA colleagues

3. Data Visualization WG Collaborations
PhUSE Working Groups
Code Sharing and Standards
Industry Groups
CTTI
Transcelerate
CTSpedia
ASA Safety Monitoring WG
Etc…
FDA

4. Interactive Analysis Approach Leveraging data visualization approach for clinical data analysis and submission
Goals of potential proof-of-concept collaboration:
Sponsor and the Agency will collaborate and evaluate the feasibility and benefits of an interactive approach from regulatory perspective
Explore solutions to some challenges facing interactive analysis
The project objective is to send an interactive analysis package in addition to the standard package for a regulatory task that a sponsor is required to fulfill, such as response to Health Authority safety inquiry and safety reporting.

5. Patient Profiles Analysis White Paper
Goals of White Paper
Conduct an updated analysis of the operational uses and approaches to creating patient profiles
Review how technology, regulations, and processes have evolved over the past 5 years
Identify emerging trends and innovative approaches to patient profiles

6. Data Visualizations Agenda: MONDAY
1:00pm - 1:15pm: Introductions & DV WG Objectives
1:15pm - 2:30pm: Interactive Analysis tool for Submissions POC with FDA
2:30pm - 3:30pm: Patient Profiles Analysis of Approaches discussion
3:30pm - 4:30pm: Development of Novel Analyses and Visualizations for Clinical Trial Review that Enhance Comprehension of Information (Analytic Visualization discussion)

7. Data Visualizations Agenda: TUESDAY
8:30am - 9:30am: Collaboration Meeting with Code Sharing Working group
9:30am - 10:30am: Recap of the Code Sharing using GitHub workshop session for the team and discuss examples in more detail
10:30am - 12pm: Poster discussion & continuation of project work

8. Come join us!
Thank you!