1. Are Interactive Graphics in a DMC Ready for Prime-Time for Better Safety Reviews?
James Buchanan, Pharm.D

2. The Challenge
Pages of data outputs to sort through…

3. The Challenge
Summary displays lack details…

4. The Inspiration
Improve upon existing static data visualizations by adding interactive features to:
Be able to filter on various data elements
Choose additional data to expand the visualization
Drill down to subject level data

5. The Inspiration
Create interactive graphics to address principal safety issues of interest:
Liver toxicity
QTc prolongation
Nephrotoxicity
Bone marrow toxicity
Drug-drug interactions

6. The Goals
A creative effort from the DIA/ASA Biopharm Working Group to develop a tool that:
Open-source – free to all users
Easy to use web-based application
Data format agnostic – ADaM & SDTM, but also other common formats
Easily configurable
Encourages collaboration between clinicians and statisticians
Applicable to industry, regulatory authorities, DMCs and academic communities

7. The Tool
Pair an interactive graphic with a clinical workflow to guide evaluations based on the medical literature.

8. The Tool
Pair an interactive graphic with a clinical workflow to guide evaluations based on the medical literature.

9. Pilot Test Results 15+ Testers from 8 Organizations
FDA, Merck, Novartis, BI, Bayer, Abbvie, Lilly, J&J, Rho
All users reported than the tool met or exceeded expectations
None found it difficult to upload data using the R package
~50 specific comments / requests
Several teams working on pilot deployments

10. 2019 Road Map V1.0 release (June 2019)
Add study drug treatment history in V1.1 (Summer 2019)
Add a full participant profile (Fall 2019)
AE, concomitant medications, narratives, etc.
2019 Presentations
FDA Innovation Forum
PHUSE Connect
World Drug Safety Conference
DIA short courses & multiple sessions
Midwest Biopharmaceutical Statistics Workshop
Rstudio Conference
RPharma Conference

11. Technical Improvements
Future Development
New Safety Domains
New Charts and Workflows for:
Nephrotoxicity
QTc Prolongation
Volcano Plot Explorer
Recurrent AEs
Technical Improvements
Easy communication between charts
Embedded access to clinical workflows within the shiny app
Optimized graphics for studies with very large data sets
Facilitated “real-time” statistical analysis
Formalized Maintenance Model

12. Lessons Learned Feedback and experience with the first tool suggests…
Collaboration between clinicians, statisticians and programmers is a powerful combination of skills
Open source tools with a medically supported workflow is a platform that has the potential to be a new lingua franca for safety evaluations
Evolution of the tool across companies has already started organically
Partnerships across industry can address a common need while reducing internal company resource expenditures to create and maintain custom tools (the interactive tools speak to a larger business need)

13. Availability https://safetygraphics.github.io/ Jim Buchanan