...
...
...
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 |
|---|
...
Bryant Chen - bryant.chen@fda.hhs.gov
Dhananjay Chhatre - dhananjay.chhatre@gilead.com
Melvin Munsaka - melvin.munsaka@abbvie.com
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 | Q4 2024 |
| Resources |
|---|
| CVARS GitHub Page |
| CVARS |