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 |
| Complete manuscript | Q2 2023Q4 2024 | status
| Resources |
|---|
| colour | Blue |
|---|---|
| title | Current Status |
- Stage 1 forest plot prototype completed
- Complete manuscript
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 |