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 | Current Status | Q1 2023
| Complete manuscript | Project MembersQ4 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 |