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. | Q32022 | |||||
| ||||||
· 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 | Organisation | |||||
Hanming Tu | Frontage Laboratories | |||||
Ivan Zou | Sanofi | |||||
Jeremy Wildfire | Gilead | |||||
Kyle Wathen | Gilead | |||||
Mary Nilsson | Eli Lilly | |||||
Mike Stackhouse | Atorus Research | |||||
| Minchen Wang | Gilead | |||||
| Neetu Sangari | Pfizer | |||||
Ting Zhang | Sanofi | |||||
| Vaishali Popat | FDA | |||||
Vipin Arora | Eli Lilly | |||||
| Zachary Skrivanek | Eli LillyQ3 2022 | |||||
| Complete manuscript | Q4 2024 |
| Resources |
|---|
| CVARS GitHub Page |
| CVARS |