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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

)Neetu Sangari

Jiang (

Pfizer

Jessica)

neetu.sangari@pfizer.com

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
Q1 2024

  • Participation at the CSS
  • Presentation at the FDA



.  Q2 2023status
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 
colourBlue
titleCurrent Status
Q1 2023
  • Finalise Stage 1 documentation 
  • Complete manuscript

Project Members 

Organisation 

Hanming Tu 

Frontage Laboratories

Ivan Zou

Sanofi

Jeremy Wildfire

Gilead

Kyle Wathen  

Gilead

Mary Nilsson  

Eli Lilly

Mike Stackhouse

Atorus ResearchMinchen WangGileadNeetu SangariPfizer

Ting Zhang

SanofiVaishali Popat

FDA

Vipin Arora

Eli Lilly 

Zachary Skrivanek
CVARS GitHub Page
CVARS
Eli Lilly