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 | |
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Melvin Munsaka |
, Abbvie |
Jiang ( |
Jessica) |
Hu, FDA | |
Neetu Sangari, Pragya Tech Leaders | neetusang@gmail.com |
Kerry Robson, PHUSE Project Assistant |
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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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colour | Blue |
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title | Current Status |
- Finalise Stage 1 documentation
- Complete manuscript
Project Members
Hanming Tu
Frontage Laboratories
Ivan Zou
Jeremy Wildfire
Gilead
Kyle Wathen
Mary Nilsson
Mike Stackhouse
Ting Zhang
FDA
Vipin Arora
Eli Lilly
CVARS GitHub Page |
CVARS |