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 |
|---|---|
| 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 |
|---|
· 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