Project Scope |
Development of R-shiny application(s)an open-source tool and package to enable thegeneration of identifiedof identified interactive plots for clinical review and direct inclusion in submission packages forsubmissions to regulatory agencies. InitialThe initial scope is to develop toolsa package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissionsubmissions to the FDA. This work is in conjunction wita collaboration among the American Statistical Association (ASA), PHUSE and the FDA. |
Project Leads |
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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 |
Kerry Robson, PHUSE Project Assistant | |
Objective | Timeline |
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Develop and Complete a prototype | Q4 2020 | Develop a R-shiny application | Q4 2020
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Continuing to build prototype.
Q1 2024 |
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Objectives & Deliverables | Timelines |
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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 |
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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