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 | |
---|---|
Melvin Munsaka |
, AbbVie |
Jiang (Jessica) Hu, FDA | |
Neetu Sangari, Pragya Tech Leaders | neetusang@gmail.com |
Alex Pearce, PHUSE Project Assistant |
| ||||||
|
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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· Stage 1 forest plot prototype completed (available @ https://github.com/phuse-org/aesummaries; example @ https://forest-plot.netlify.app/).
· Requirements for aesthetic improvement for the forest plot update for the Stage 1 prototype have been finalised.
· Requirements for the volcano plot have been finalised.
· Draft outline and literature review for the accompanying paper for Stage 1 has been completed and team are now working on the White Paper.
CVARS GitHub Page |
CVARS |
Project Members
Hanming Tu
Frontage Laboratories
Ivan Zou
Jeremy Wildfire
Gilead
Kyle Wathen
Mary Nilsson
Mike Stackhouse
Ting Zhang
FDA
Vipin Arora
Eli Lilly