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 and Deliverables | Timelines | |||||
|---|---|---|---|---|---|---|
| Develop and Complete a prototype | Q2 2021 | |||||
| Develop a R-shiny application | Q3 2021 | |||||
| Q22021||||||
| Built initial prototype with some functionality. | ||||||
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 Lilly||||
Q2 2024 | ||||||
|
| 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 |
|---|
| CVARS GitHub Page |
| CVARS |