Clinical Visual Analytics for Review and Submission (CVARS)

Project Scope

Development of an open-source tool and package to enable generation of identified interactive plots for clinical review and direct inclusion in submissions to regulatory agencies. The initial scope is to develop a package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissions to the FDA. This work is a collaboration among the American Statistical Association (ASA), PHUSE and the FDA.

Project Leads

Email

Melvin Munsaka, AbbVie

melvin.munsaka@abbvie.com

Jiang (Jessica) Hu, FDA

jiang.hu@fda.hhs.gov

Neetu Sangari, Pragya Tech Leadersneetusang@gmail.com
Alex Pearce, PHUSE Project Assistant

alexandra@phuse.global

CURRENT STATUS Q3 2024

  • Participation at the CSS
  • Invited poster at JSM outline and content 
Objectives & DeliverablesTimelines
An open-source R Shiny tool for generating the plots and associated outputs and an accompanying paper for the toolQ3 2022
Complete manuscriptQ4 2024