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 | |
| Status | colour | Blue
| title | Current Status |
| Complete manuscript | |
| Q4 2024 | 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 Lilly
| Resources |
|---|
| CVARS GitHub Page |
| CVARS |