Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Image Modified







Project Scope

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



Project Leads

Email

Melvin Munsaka

(

, Abbvie

)

melvin.munsaka@abbvie.com

Neetu Sangari

Jiang (

Pfizer

Jessica)

neetu.sangari@pfizer.comNicola Newton (PHUSE, Project Assistant)nicky@phuse

Hu, FDA

jiang.hu@fda.hhs.gov

Neetu Sangari, Pragya Tech Leadersneetusang@gmail.com
Kerry Robson, PHUSE Project Assistant

kerry@phuse.global


Status
colourBlue
titleCurrent Status
Q2 2023 Q1 2024

  • Participation at the CSS
  • Presentation at the FDA
  • Stage 1 forest plot prototype completed​
  • Complete manuscript



Objectives & DeliverablesTimelines
An open-source R Shiny tool for generating the plots and associated outputs and an accompanying paper for the tool
.  
Q3 2022
Complete manuscript
Q4 2024


Resources 
CVARS GitHub Page
CVARS
Q2 2023