1. Specific Safety Monitoring Tools & How This Will Benefit Drug Safety
Jim Buchanan, PharmD
Covilance LLC

2. Safety Evaluation Toolkit
Methodology Guidance
FDA Pre-Marketing Risk Assessment
FDA Good Pharmacovigilance Practices and Pharmacoepidemiology
FDA Reviewer Guidance
Proprietary Tools
Spotfire, JMP, Qlik, Tableau, J Review, etc.
Open Source Tools
CTSPedia, Rho Safety Monitoring

3. CTSPedia

4. Rho Safety Monitoring

5. Next Generation Safety Tools
Desired Features
Interactive functionality
Open source
Provide a workflow to cover essential analyses
Base the analyses in established science

6. ASA-DIA Biopharm Safety Working Group
Workstream 1b: Safety Evaluation and Identification of Risk
Identify common safety questions
Develop interactive signal detection and evaluation tools
Make available to drug safety/pharmacovigilance departments, safety assessment committees, data monitoring committees, regulatory authorities
Provide training to support the adoption and efficient use of the tools

7. ASA-DIA Biopharm Safety Working Group
Initial Safety Topics to Target:
Hepatotoxicity
QT prolongation
Adverse event evaluation

8. Interactive eDISH plot – Design Principals
Free and Open Source – GitHub Repo1 – Demo Page2
Leverage existing clinical data standards (AdAM, SDTM)
Graphics created with standard web technology (javascript, html, css)
Minimal dependencies (d3.js3, webcharts.js4)
Planning to release an R package with shiny and htmlwidgets, but graphics can work on many platforms. 1 2 3 4

9. Interactive eDISH plot – Population View2
Overview
Interactive eDish plot with one point per participant showing maximal ALT and TB over the course of the study.
Features
eDish Scatter plot
Interactive Grouping sets point color
Toggle between eDish, mDish and absolute measures
Interactive cut points with linked summary table
Option to set point radius based on 3rd measure
Choose Linear or Logarithmic axes
Fill points based on timing of peak values
Interactive filters
Chart reset
Marginal box plots distributions
Hover on a point to see exact values
Click a point for participant details view 10 2 3 4 1 11 5 6 10 7 4 8 9

10. Interactive eDISH plot – Participant View
Overview
Click a point to see details for a selected participant.
Features
Plot showing participant’s lab values across visits
Participant details section with demographic summary and optional link to external participant profile
Longitudinal Plot of key lab values vs upper limit of normal
Lab summary table with spark lines 1 2 3 4