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 |
---|
Bryant Chen
bryant.chen@fda.hhs.gov
Dhananjay Chhatre
dhananjay.chhatre@gilead.com
Melvin Munsaka, AbbVie |
Key Milestones
Jiang (Jessica) Hu, FDA | |
Neetu Sangari, Pragya Tech Leaders | neetusang@gmail.com |
Alex Pearce, PHUSE Project Assistant | |
Objective | Timeline |
---|---|
Develop and Complete a prototype | Q4 2020 | Develop a R-shiny application | Q4 2020
|
Continuing to build prototype.
Q2 2024 |
|
Objectives & Deliverables | Timelines |
---|---|
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 |
Project Members
Alex Dmitrienko
Industry
Hanming Tu
Frontage
Ivan Zou
Jeremy Wildfire
Gilead
Kyle Wathen
Mary Nilsson
Mike Stackhouse
Ting Zhang
FDA
Varora
Eli Lilly