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, AbbVie |
Key Milestones
Jiang (Jessica) Hu, FDA | |
| Neetu Sangari, Pragya Tech Leaders | neetusang@gmail.com |
| Alex Pearce, PHUSE Project Assistant |
|
Continuing to build prototype.
Project Members
Alex Dmitrienko
Industry
Hanming Tu
Frontage
Ivan Zou
Jeremy Wildfire
Gilead
Kyle Wathen
Mary Nilsson
Mike Stackhouse
Ting Zhang
FDA
Varora
Eli Lilly
Volunteer Today
Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.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 |