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 |
| statusComplete manuscript | colourQ4 2024Blue |
| 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.
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 |